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ysteroscopy-cleared/2026-09-15T00:27:06.000Zhttps://www.fdaweb.com/audentes-therapeutics-regenerative-medicine-designation/2026-09-15T00:27:04.000Zhttps://www.fdaweb.com/merck-expanded-label-for-keytruda-approved/2026-09-15T00:27:03.000Zhttps://www.fdaweb.com/biomerieux-recalls-vitek-2-ast-p631/2026-09-15T00:27:01.000Zhttps://www.fdaweb.com/info-collection-extension-on-dispute-resolution-guide/2026-09-15T00:27:00.000Zhttps://www.fdaweb.com/panel-to-review-pediatric-drug-safety/2026-09-15T00:26:58.000Zhttps://www.fdaweb.com/guide-on-quality-attributes-for-chewable-tablets/2026-09-15T00:26:56.000Zhttps://www.fdaweb.com/guide-microdose-radiopharm-diagnostic-drugs/2026-09-15T00:26:55.000Zhttps://www.fdaweb.com/comments-extended-on-animal-drug-trial-design-notice/2026-09-15T00:26:53.000Zhttps://www.fdaweb.com/info-collection-extension-for-samples-and-protocols/2026-09-15T00:26:51.000Zhttps://www.fdaweb.com/panel-to-review-sequent-aneurysm-embolization-device/2026-09-15T00:26:49.000Zhttps://www.fdaweb.com/latest-federal-register-notices-191/2026-09-15T00:26:46.000Zhttps://www.fdaweb.com/mortality-concerns-with-syncardia-artificial-heart/2026-09-15T00:26:45.000Zhttps://www.fdaweb.com/quality-metrics-proposal-period-extended/2026-09-15T00:26:43.000Zhttps://www.fdaweb.com/info-collection-extension-for-generic-development-guide/2026-09-15T00:26:41.000Zhttps://www.fdaweb.com/device-alternative-malfunction-reporting/2026-09-15T00:26:40.000Zhttps://www.fdaweb.com/proposal-to-classify-device-accessories-into-class-1/2026-09-15T00:26:38.000Zhttps://www.fdaweb.com/fda-warns-on-china-sourced-api/2026-09-15T00:26:36.000Zhttps://www.fdaweb.com/fda-clears-transcranial-magnetic-stimulation-for-ocd/2026-09-15T00:26:34.000Zhttps://www.fdaweb.com/workshop-on-microbiome-based-products/2026-09-15T00:26:33.000Zhttps://www.fdaweb.com/fda-looking-for-new-real-world-data-uses/2026-09-15T00:26:31.000Zhttps://www.fdaweb.com/new-fda-medical-device-initiatives-under-mdufa/2026-09-15T00:26:29.000Zhttps://www.fdaweb.com/fda-playing-active-drug-pricing-role-analysis/2026-09-15T00:26:28.000Zhttps://www.fdaweb.com/fda-releases-2-zhejiang-huahai-inspection-483s/2026-09-15T00:26:26.000Zhttps://www.fdaweb.com/panel-to-discuss-2019-flu-vaccine/2026-09-15T00:26:24.000Zhttps://www.fdaweb.com/comments-sought-on-ind-surveys-under-user-fee-program/2026-09-15T00:26:22.000Zhttps://www.fdaweb.com/medical-device-security-moving-in-right-direction-article/2026-09-15T00:26:21.000Zhttps://www.fdaweb.com/fda-planning-microbiome-product-conference/2026-09-15T00:26:19.000Zhttps://www.fdaweb.com/drug-user-fee-program-fee-invoices-mailed/2026-09-15T00:26:18.000Zhttps://www.fdaweb.com/improper-influence-on-fda-science-survey-says/2026-09-15T00:26:16.000Zhttps://www.fdaweb.com/evoke-pharma-nda-for-diabetic-gastroparesis-therapy/2026-09-15T00:26:14.000Zhttps://www.fdaweb.com/sun-pharma-tear-production-drug-approved/2026-09-15T00:26:13.000Zhttps://www.fdaweb.com/endo-drug-compounding-suit-moving-forward/2026-09-15T00:26:11.000Zhttps://www.fdaweb.com/fda-approves-eisai-and-mercks-lenvima/2026-09-15T00:26:10.000Zhttps://www.fdaweb.com/changes-sought-in-lpad-draft-guidance/2026-09-15T00:26:08.000Zhttps://www.fdaweb.com/priority-preview-voucher-granted-to-ultragenyx/2026-09-15T00:26:06.000Zhttps://www.fdaweb.com/info-collection-extension-on-adverse-event-guide/2026-09-15T00:26:05.000Zhttps://www.fdaweb.com/support-questions-on-antibiotic-pathway-guidance/2026-09-15T00:26:03.000Zhttps://www.fdaweb.com/suggestions-for-hde-draft-guidance-changes/2026-09-15T00:26:01.000Zhttps://www.fdaweb.com/fda-veterinary-medicine-opioid-resources/2026-09-15T00:25:59.000Zhttps://www.fdaweb.com/fda-approves-expanded-use-for-vertex-kalydeco/2026-09-15T00:25:57.000Zhttps://www.fdaweb.com/fda-approves-grifols-zika-virus-assay/2026-09-15T00:25:55.000Zhttps://www.fdaweb.com/westminster-pharmaceuticals-recalls-thyroid-drugs/2026-09-15T00:25:54.000Zhttps://www.fdaweb.com/joint-advisory-panel-to-discuss-modernizing-drug-assessments/2026-09-15T00:25:52.000Zhttps://www.fdaweb.com/cders-patrick-frey-leaving-for-amgen/2026-09-15T00:25:50.000Zhttps://www.fdaweb.com/fda-nih-reducing-regulatory-oversight-of-gene-therapy-trials/2026-09-15T00:25:48.000Zhttps://www.fdaweb.com/comment-period-reopened-on-animal-drug-impurities/2026-09-15T00:25:46.000Zhttps://www.fdaweb.com/joint-fda-panel-looks-at-modernizing-nda-assessments/2026-09-15T00:25:45.000Zhttps://www.fdaweb.com/cgmp-issues-at-indias-apotex-research-private/2026-09-15T00:25:43.000Zhttps://www.fdaweb.com/biosig-tech-gets-pure-ep-system-cleared/2026-09-15T00:25:41.000Zhttps://www.fdaweb.com/moleculight-gains-de-novo-marketing-for-wound-imaging/2026-09-15T00:25:40.000Zhttps://www.fdaweb.com/more-recalls-with-510-k-s-than-pmas-study/2026-09-15T00:25:38.000Zhttps://www.fdaweb.com/fda-withdraws-20-unmarketed-andas/2026-09-15T00:25:36.000Zhttps://www.fdaweb.com/info-request-on-dtc-study-sent-to-omb/2026-09-15T00:25:34.000Zhttps://www.fdaweb.com/paramesh-banerji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roat-cancers-etc/2026-09-14T23:11:24.000Zhttps://www.fdaweb.com/absorbable-perirectal-spacer-into-class-2/2026-09-14T23:11:22.000Zhttps://www.fdaweb.com/oig-asks-phrma-companies-for-free-drugs/2026-09-14T23:11:20.000Zhttps://www.fdaweb.com/auromedics-pharma-recalls-ampicillin-and-sulbactam-vials/2026-09-14T23:11:17.000Zhttps://www.fdaweb.com/fda-releases-dr-reddys-establishment-report/2026-09-14T23:11:15.000Zhttps://www.fdaweb.com/sca-pharmaceuticals-fda-483-released/2026-09-14T23:11:13.000Zhttps://www.fdaweb.com/watson-chlorthalidone-anda-approval-still-in-effect-fda/2026-09-14T23:11:12.000Zhttps://www.fdaweb.com/draft-guide-on-anda-submission-mistakes/2026-09-14T23:11:10.000Zhttps://www.fdaweb.com/2-4-billion-in-2017-healthcare-false-claim-settlements/2026-09-14T23:11:08.000Zhttps://www.fdaweb.com/reject-dtc-tax-exemption-idea-wlf/2026-09-14T23:11:06.000Zhttps://www.fdaweb.com/fda-warns-american-cryostem-about-atcell-violations/2026-09-14T23:11:04.000Zhttps://www.fdaweb.com/fda-grand-rounds-alzheimers-webcast/2026-09-14T23:11:00.000Zhttps://www.fdaweb.com/iteos-regains-rights-from-pfizer-for-oncology-therapy/2026-09-14T23:10:57.000Zhttps://www.fdaweb.com/cervical-intraepithelial-neoplasia-tests-put-into-class-2/2026-09-14T23:10:55.000Zhttps://www.fdaweb.com/fda-clears-cerebrotech-visor-fluid-monitor-2/2026-09-14T23:10:53.000Zhttps://www.fdaweb.com/praise-for-gottlieb-amid-fda-successes-in-2017/2026-09-14T23:10:51.000Zhttps://www.fdaweb.com/fda-clears-cerebrotech-visor-fluid-monitor/2026-09-14T23:10:49.000Zhttps://www.fdaweb.com/draft-guide-on-certain-contraceptive-labeling/2026-09-14T23:10:47.000Zhttps://www.fdaweb.com/pediatric-advisory-committee-meeting-in-march/2026-09-14T23:10:46.000Zhttps://www.fdaweb.com/groups-oppose-azar-hhs-nomination/2026-09-14T23:10:44.000Zhttps://www.fdaweb.com/draft-guide-on-hypogonadotropic-hypogonadism-drugs/2026-09-14T23:10:41.000Zhttps://www.fdaweb.com/fda-clears-zimmer-biomet-shoulder-system/2026-09-14T23:10:40.000Zhttps://www.fdaweb.com/fda-denies-allergan-petition-on-restasis-bioequivalence/2026-09-14T23:10:37.000Zhttps://www.fdaweb.com/steps-to-ease-generic-drug-review/2026-09-14T23:10:35.000Zhttps://www.fdaweb.com/oig-report-examines-misclassified-drugs-in-rebate-program/2026-09-14T23:10:33.000Zhttps://www.fdaweb.com/former-fda-chief-information-officer-joins-datavant/2026-09-14T23:10:30.000Zhttps://www.fdaweb.com/pharmedium-recalls-drug-products-after-review/2026-09-14T23:10:28.000Zhttps://www.fdaweb.com/joint-advisory-committee-to-review-pain-drug/2026-09-14T23:10:26.000Zhttps://www.fdaweb.com/priority-review-voucher-issued-to-spark-therapeutics/2026-09-14T23:10:24.000Zhttps://www.fdaweb.com/3-inspection-observations-in-krs-fda-483/2026-09-14T23:10:22.000Zhttps://www.fdaweb.com/fdara-marketing-status-report-request/2026-09-14T23:10:20.000Zhttps://www.fdaweb.com/150-million-androgel-verdict-overturned/2026-09-14T23:10:18.000Zhttps://www.fdaweb.com/fda-looking-for-patient-engagement-collaborative-members/2026-09-14T23:10:16.000Zhttps://www.fdaweb.com/recent-federal-register-postings/2026-09-14T23:10:14.000Zhttps://www.fdaweb.com/latest-fda-warning-letters-144/2026-09-14T23:10:11.000Zhttps://www.fdaweb.com/fda-approves-luxturna-for-rare-vision-loss/2026-09-14T23:10:09.000Zhttps://www.fdaweb.com/fda-risk-based-enforcement-for-homeopathic-drugs/2026-09-14T23:10:07.000Zhttps://www.fdaweb.com/senators-question-drug-import-enforcement/2026-09-14T23:10:05.000Zhttps://www.fdaweb.com/fda-clears-gammapod-breast-cancer-treatment/2026-09-14T23:10:03.000Zhttps://www.fdaweb.com/fda-permits-marketing-of-dermapace-foot-ulcer-device/2026-09-14T23:10:00.000Zhttps://www.fdaweb.com/cder-approvals-double-to-46-innovative-products/2026-09-14T23:09:57.000Zhttps://www.fdaweb.com/fda-issues-2-drug-communication-guidances/2026-09-14T23:09:55.000Zhttps://www.fdaweb.com/3rd-circuit-expanded-antitrust-law-wlf/2026-09-14T23:09:53.000Zhttps://www.fdaweb.com/some-otc-antiseptic-ingredients-not-grase/2026-09-14T23:09:50.000Zhttps://www.fdaweb.com/some-tasigna-patients-may-be-able-to-stop-treatment-fda/2026-09-14T23:09:49.000Zhttps://www.fdaweb.com/no-orphan-drug-designation-for-some-pediatric-subpopulations/2026-09-14T23:09:45.000Zhttps://www.fdaweb.com/fda-proposed-voluntary-malfunction-summary-reporting-program/2026-09-14T23:09:42.000Zhttps://www.fdaweb.com/anda-letters-guidance/2026-09-14T23:09:40.000Zhttps://www.fdaweb.com/fda-approves-giapreza-for-hypotension/2026-09-14T23:09:39.000Zhttps://www.fdaweb.com/fda-warns-canadas-deserving-health-international/2026-09-14T23:09:37.000Zhttps://www.fdaweb.com/no-asthma-increase-with-laba-ics-combination-fda/2026-09-14T23:09:36.000Zhttps://www.fdaweb.com/physio-control-recalls-defibrillator-electrodes/2026-09-14T23:09:34.000Zhttps://www.fdaweb.com/sterilmed-recalls-introducer-sheath/2026-09-14T23:09:33.000Zhttps://www.fdaweb.com/fda-accepts-seattle-genetics-sbla-for-adcetris/2026-09-14T23:09:31.000Zhttps://www.fdaweb.com/drug-marketing-warning-letter-sent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us-pharma-gets-complete-response-letter/2026-09-14T18:47:17.000Zhttps://www.fdaweb.com/abbott-withdraws-trifecta-heart-valves/2026-09-14T18:47:15.000Zhttps://www.fdaweb.com/info-collection-on-combo-product-jurisdiction-2/2026-09-14T18:47:11.000Zhttps://www.fdaweb.com/guide-on-biosimilar-user-fees/2026-09-14T18:47:09.000Zhttps://www.fdaweb.com/ge-recalls-trusignal-spo2-sensors/2026-09-14T18:47:07.000Zhttps://www.fdaweb.com/fda-switzerland-recognizing-each-others-inspections/2026-09-14T18:47:05.000Zhttps://www.fdaweb.com/fda-ema-collaborate-on-post-approval-changes/2026-09-14T18:47:03.000Zhttps://www.fdaweb.com/fda-not-yet-implementing-otc-drug-reforms-gao/2026-09-14T18:47:02.000Zhttps://www.fdaweb.com/info-collection-on-device-improvement-program/2026-09-14T18:47:01.000Zhttps://www.fdaweb.com/guide-on-devices-opioid-use-disorder/2026-09-14T18:46:59.000Zhttps://www.fdaweb.com/opioid-disorder-innovative-devices/2026-09-14T18:46:57.000Zhttps://www.fdaweb.com/compliance-woes-at-wegovy-syringe-plant/2026-09-14T18:46:55.000Zhttps://www.fdaweb.com/fda-wont-review-toriluzole-nda/2026-09-14T18:46:54.000Zhttps://www.fdaweb.com/rfk-jr-for-fda-or-cdc-desantis/2026-09-14T18:46:52.000Zhttps://www.fdaweb.com/drug-shortage-legislative-fix-introduced/2026-09-14T18:46:51.000Zhttps://www.fdaweb.com/abiomed-impella-pump-recall/2026-09-14T18:46:49.000Zhttps://www.fdaweb.com/merck-pneumococcal-vaccine-hits-phase-3-marks/2026-09-14T18:46:48.000Zhttps://www.fdaweb.com/house-delays-fda-budget-floor-vote/2026-09-14T18:46:46.000Zhttps://www.fdaweb.com/ultrasight-ultrasound-guidance-software-cleared/2026-09-14T18:46:45.000Zhttps://www.fdaweb.com/contact-lens-care-product-guidance/2026-09-14T18:46:43.000Zhttps://www.fdaweb.com/guide-on-drug-quality-consensus-standards/2026-09-14T18:46:42.000Zhttps://www.fdaweb.com/alert-update-on-vessel-occlusion-cadt-devices/2026-09-14T18:46:41.000Zhttps://www.fdaweb.com/fentanyl-detection-kit-gains-clearance/2026-09-14T18:46:40.000Zhttps://www.fdaweb.com/panel-to-review-brainstorm-als-submission/2026-09-14T18:46:38.000Zhttps://www.fdaweb.com/fda-debars-daffin-over-covid-treatments/2026-09-14T18:46:36.000Zhttps://www.fdaweb.com/integrating-ora-in-centers-has-risks-analysis/2026-09-14T18:46:34.000Zhttps://www.fdaweb.com/recall-unapproved-phenobarb-products-sun/2026-09-14T18:46:33.000Zhttps://www.fdaweb.com/central-admixture-fda-483/2026-09-14T18:46:32.000Zhttps://www.fdaweb.com/fda-hits-medical-device-intended-use-creep/2026-09-14T18:46:30.000Zhttps://www.fdaweb.com/voluntary-consensus-standards-guidance/2026-09-14T18:46:29.000Zhttps://www.fdaweb.com/octapharma-nda-for-warfarin-reverser-okd/2026-09-14T18:46:28.000Zhttps://www.fdaweb.com/abbott-recalls-amplatzer-delivery-sheath/2026-09-14T18:46:25.000Zhttps://www.fdaweb.com/defender-pharma-nda-for-scopolamine-gel/2026-09-14T18:46:23.000Zhttps://www.fdaweb.com/beckman-coulter-chemistry-analyzer-cleared/2026-09-14T18:46:22.000Zhttps://www.fdaweb.com/dismissal-sought-in-fda-483-anonymity-suit/2026-09-14T18:46:19.000Zhttps://www.fdaweb.com/3rd-circuit-flunks-fda-again-over-illegal-generics/2026-09-14T18:46:18.000Zhttps://www.fdaweb.com/stratus-illegally-marketing-biologics-fda/2026-09-14T18:46:16.000Zhttps://www.fdaweb.com/fda-denies-2-vanda-tasimelteon-petitions/2026-09-14T18:46:14.000Zhttps://www.fdaweb.com/fda-approves-eyelid-mite-disease-drug/2026-09-14T18:46:13.000Zhttps://www.fdaweb.com/cdrh-adds-device-sterilization-standards/2026-09-14T18:46:11.000Zhttps://www.fdaweb.com/fda-expanding-cure-id/2026-09-14T18:46:09.000Zhttps://www.fdaweb.com/guide-on-drug-dna-reactive-impurities/2026-09-14T18:46:07.000Zhttps://www.fdaweb.com/12-catalent-inspection-observations/2026-09-14T18:46:05.000Zhttps://www.fdaweb.com/fda-told-generally-accepted-often-isnt/2026-09-14T18:46:03.000Zhttps://www.fdaweb.com/meridian-bios-h-pylori-test-cleared/2026-09-14T18:46:01.000Zhttps://www.fdaweb.com/fda-downplays-impact-after-pfizer-tornado/2026-09-14T18:46:00.000Zhttps://www.fdaweb.com/ich-mutagenic-impurities-drug-guidance/2026-09-14T18:45:59.000Zhttps://www.fdaweb.com/fda-spending-bill-will-see-veto-white-house/2026-09-14T18:45:58.000Zhttps://www.fdaweb.com/syndax-incyte-plan-bla-for-axatilimab/2026-09-14T18:45:56.000Zhttps://www.fdaweb.com/horizon-misses-on-lupus-phase-2-endpoint/2026-09-14T18:45:55.000Zhttps://www.fdaweb.com/nesa-medtech-fibroid-mapping-app-cleared/2026-09-14T18:45:53.000Zhttps://www.fdaweb.com/fda-oks-verrica-nda-for-molluscum-topical/2026-09-14T18:45:51.000Zhttps://www.fdaweb.com/datascope-recalls-cardiosave-intraaortic-pumps/2026-09-14T18:45:50.000Zhttps://www.fdaweb.com/adc-therapeutics-discontinues-phase-2-trial/2026-09-14T18:45:45.000Zhttps://www.fdaweb.com/bufferin-nda-withdrawn-by-fda/2026-09-14T18:45:44.000Zhttps://www.fdaweb.com/fda-oks-emergents-anthrax-vaccine/2026-09-14T18:45:42.000Zhttps://www.fdaweb.com/peter-stoll-guilty-on-medical-device-felony-count/2026-09-14T18:45:41.000Zhttps://www.fdaweb.com/cders-rosemary-roberts-is-retiring/2026-09-14T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imilar-bla-accepted/2026-09-14T18:44:02.000Zhttps://www.fdaweb.com/fda-guide-on-postmarketing-noncompliance-good-cause/2026-09-14T18:43:58.000Zhttps://www.fdaweb.com/ex-sales-rep-debarment-withdrawn/2026-09-14T18:43:57.000Zhttps://www.fdaweb.com/panel-to-discuss-womb-tech-devices/2026-09-14T18:43:55.000Zhttps://www.fdaweb.com/oncology-drug-pilot-on-ldt-performance-criteria/2026-09-14T18:43:53.000Zhttps://www.fdaweb.com/zyto-illegally-marketing-galvanic-skin-device-fda/2026-09-14T18:43:51.000Zhttps://www.fdaweb.com/fda-hernia-repair-surgical-mesh-info/2026-09-14T18:43:49.000Zhttps://www.fdaweb.com/draeger-recalls-ventilator-over-battery-issues/2026-09-14T18:43:47.000Zhttps://www.fdaweb.com/cgmp-other-issues-at-neilmed-pharmaceuticals/2026-09-14T18:43:46.000Zhttps://www.fdaweb.com/disclose-drug-supplement-animal-ingredients-petition/2026-09-14T18:43:44.000Zhttps://www.fdaweb.com/boston-scientific-brain-stimulation-software-okd/2026-09-14T18:43:43.000Zhttps://www.fdaweb.com/fda-warns-2-firms-on-human-cells-tissues/2026-09-14T18:43:42.000Zhttps://www.fdaweb.com/most-common-2022-bimo-violations/2026-09-14T18:43:40.000Zhttps://www.fdaweb.com/consumer-groups-sought-for-advisory-panels/2026-09-14T18:43:39.000Zhttps://www.fdaweb.com/guide-on-metabolism-inborn-errors/2026-09-14T18:43:37.000Zhttps://www.fdaweb.com/beigene-snda-for-brukinsa-in-lymphoma/2026-09-14T18:43:34.000Zhttps://www.fdaweb.com/fda-wants-more-psa-applicants/2026-09-14T18:43:31.000Zhttps://www.fdaweb.com/panel-to-discuss-decongestant-phenylephrine/2026-09-14T18:43:29.000Zhttps://www.fdaweb.com/lymphoma-trial-enrollment-paused-after-7-deaths/2026-09-14T18:43:28.000Zhttps://www.fdaweb.com/praise-for-fda-final-pfdd-guidance/2026-09-14T18:43:26.000Zhttps://www.fdaweb.com/megadyne-recalls-mega-patient-electrodes/2026-09-14T18:43:25.000Zhttps://www.fdaweb.com/innovative-manufacturing-workshop-positive-comments/2026-09-14T18:43:23.000Zhttps://www.fdaweb.com/no-higher-death-risk-in-paclitaxel-coated-devices-fda/2026-09-14T18:43:21.000Zhttps://www.fdaweb.com/metabolism-inborn-errors-guidance/2026-09-14T18:43:20.000Zhttps://www.fdaweb.com/info-collection-on-euas-for-medical-products/2026-09-14T18:43:18.000Zhttps://www.fdaweb.com/more-study-of-patient-reported-frailty-needed-fda/2026-09-14T18:43:17.000Zhttps://www.fdaweb.com/scotus-should-hear-label-highlights-appeal-phrma/2026-09-14T18:43:16.000Zhttps://www.fdaweb.com/fda-enforcement-discretion-policy-for-pandemic-tests/2026-09-14T18:43:14.000Zhttps://www.fdaweb.com/fda-stalls-xspray-pharmas-dasynoc/2026-09-14T18:43:13.000Zhttps://www.fdaweb.com/takeda-withdraws-bla-for-dengue-vaccine/2026-09-14T18:43:11.000Zhttps://www.fdaweb.com/fda-clears-avatar-vr-surgical-planner/2026-09-14T18:43:07.000Zhttps://www.fdaweb.com/cipla-recalls-6-albuterol-sulfate-aerosol-batches/2026-09-14T18:43:05.000Zhttps://www.fdaweb.com/fda-lifts-partial-hold-on-curis-leukemia-trial/2026-09-14T18:43:03.000Zhttps://www.fdaweb.com/dtc-guidance-may-signal-enforcement-shift-attorneys/2026-09-14T18:43:01.000Zhttps://www.fdaweb.com/illumina-cybersecurity-vulnerability-is-class-2-fda/2026-09-14T18:42:59.000Zhttps://www.fdaweb.com/ipsen-planning-fda-elifibranor-application/2026-09-14T18:42:58.000Zhttps://www.fdaweb.com/fda-full-approval-for-eisais-leqembi/2026-09-14T18:42:57.000Zhttps://www.fdaweb.com/guidance-explains-fda-503b-wholesaling-ban/2026-09-14T18:42:55.000Zhttps://www.fdaweb.com/crl-for-regeneron-aflibercept-bla/2026-09-14T18:42:54.000Zhttps://www.fdaweb.com/fda-to-again-try-to-regulate-ldts-attorneys/2026-09-14T18:42:51.000Zhttps://www.fdaweb.com/fda-oks-systimmune-phase-1-lung-cancer-study/2026-09-14T18:42:50.000Zhttps://www.fdaweb.com/fda-actions-follow-advisors-88-of-time-analysis/2026-09-14T18:42:48.000Zhttps://www.fdaweb.com/8-observations-on-ipca-labs-fda-483/2026-09-14T18:42:47.000Zhttps://www.fdaweb.com/crl-for-amneal-parkinsons-drug/2026-09-14T18:42:45.000Zhttps://www.fdaweb.com/cder-site-selection-model-mapp/2026-09-14T18:42:44.000Zhttps://www.fdaweb.com/federal-register-notices-7-3-to-7-10/2026-09-14T18:42:43.000Zhttps://www.fdaweb.com/cdrh-moving-to-electronic-export-docs/2026-09-14T18:42:42.000Zhttps://www.fdaweb.com/novartis-leqvio-gets-expanded-label/2026-09-14T18:42:40.000Zhttps://www.fdaweb.com/29-page-intas-fda-483/2026-09-14T18:42:39.000Zhttps://www.fdaweb.com/outset-medical-gets-tablo-warning-letter/2026-09-14T18:42:38.000Zhttps://www.fdaweb.com/sarepta-sells-priority-voucher-for-102-million/2026-09-14T18:42:36.000Zhttps://www.fdaweb.com/hemogenyx-car-t-therapy-on-clinical-hold/2026-09-14T18:42:34.000Zhttps://www.fdaweb.com/uniform-ai-ml-marketing-guidelines-needed-study/2026-09-14T18:42:32.000Zhttps://www.fdaweb.com/vcn-01-orphan-status-for-pancreatic-cancer/2026-09-14T18:42:30.000Zhttps://www.fdaweb.com/madrigal-rolling-nda-for-resmetirom/2026-09-14T18:42:28.000Zhttps://www.fdaweb.com/teleflex-recalls-endotracheal-tubes/2026-09-14T18:42:26.000Zhttps://www.fdaweb.com/house-bill-on-provisional-drug-approvals/2026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lears-2-thermo-scientific-tests/2026-09-14T17:48:11.000Zhttps://www.fdaweb.com/doj-defends-fraud-on-fda-in-1-specific-case/2026-09-14T17:48:10.000Zhttps://www.fdaweb.com/some-mole-products-can-injure-scar-fda/2026-09-14T17:48:09.000Zhttps://www.fdaweb.com/foundation-medicine-companion-diagnostic-approved/2026-09-14T17:48:08.000Zhttps://www.fdaweb.com/concerns-on-drug-quality-metrics-proposal-aired/2026-09-14T17:48:07.000Zhttps://www.fdaweb.com/5-observations-on-bpi-labs-fda-483/2026-09-14T17:48:06.000Zhttps://www.fdaweb.com/cruz-others-question-fda-on-covid-19-vaccines-for-babies/2026-09-14T17:48:05.000Zhttps://www.fdaweb.com/consider-new-approach-to-monitor-drug-quality/2026-09-14T17:48:04.000Zhttps://www.fdaweb.com/last-minute-manufacturing-data-delays-novavax-vaccine/2026-09-14T17:48:03.000Zhttps://www.fdaweb.com/end-patent-thickets-senators/2026-09-14T17:48:02.000Zhttps://www.fdaweb.com/fda-accepts-few-labeling-changes-for-propecia/2026-09-14T17:48:01.000Zhttps://www.fdaweb.com/ge-ventilator-backup-battery-class-1-recall/2026-09-14T17:47:59.000Zhttps://www.fdaweb.com/house-passes-user-fee-fda-amendments-bill/2026-09-14T17:47:59.000Zhttps://www.fdaweb.com/4-advisory-committees-renewed-for-2-years/2026-09-14T17:47:57.000Zhttps://www.fdaweb.com/info-collection-on-new-animal-drug-submissions/2026-09-14T17:47:56.000Zhttps://www.fdaweb.com/superior-response-in-covid-omicron-booster-moderna/2026-09-14T17:47:55.000Zhttps://www.fdaweb.com/drug-device-user-interface-mapp/2026-09-14T17:47:54.000Zhttps://www.fdaweb.com/legislation-to-expand-affordable-otc-birth-control/2026-09-14T17:47:53.000Zhttps://www.fdaweb.com/apply-covid-lessons-to-other-diseases-drug-companie/2026-09-14T17:47:52.000Zhttps://www.fdaweb.com/aam-issues-with-fda-quality-metrics-program/2026-09-14T17:47:51.000Zhttps://www.fdaweb.com/medtronic-pump-implant-kit-recall-is-class-1/2026-09-14T17:47:50.000Zhttps://www.fdaweb.com/bill-to-tighten-device-signal-communications/2026-09-14T17:47:49.000Zhttps://www.fdaweb.com/dupixent-approved-for-pediatric-atopic-dermatitis/2026-09-14T17:47:48.000Zhttps://www.fdaweb.com/outlook-therapeutics-refiling-bla-in-september/2026-09-14T17:47:47.000Zhttps://www.fdaweb.com/accreditation-body-participation-in-asca-pilot/2026-09-14T17:47:46.000Zhttps://www.fdaweb.com/allogene-therapeutics-gets-fda-rmat-designation/2026-09-14T17:47:45.000Zhttps://www.fdaweb.com/fda-considering-radiation-sterilization-master-file-pilot/2026-09-14T17:47:44.000Zhttps://www.fdaweb.com/pma-safety-and-effectiveness-summaries-available/2026-09-14T17:47:43.000Zhttps://www.fdaweb.com/fda-approves-diabetes-drug-for-weight-loss/2026-09-14T17:47:42.000Zhttps://www.fdaweb.com/nephron-sterile-compounding-fda-483/2026-09-14T17:47:41.000Zhttps://www.fdaweb.com/opdp-faults-roszet-promotion/2026-09-14T17:47:40.000Zhttps://www.fdaweb.com/senators-introducing-interchangeable-biologics-bill/2026-09-14T17:47:39.000Zhttps://www.fdaweb.com/whistleblower-sues-lilly-over-gmp-related-termination/2026-09-14T17:47:38.000Zhttps://www.fdaweb.com/fda-will-update-apec-toolkit-verbois/2026-09-14T17:47:37.000Zhttps://www.fdaweb.com/bms-settles-hiv-medication-suit-for-10-8-million/2026-09-14T17:47:36.000Zhttps://www.fdaweb.com/fda-questions-safety-efficacy-of-bluebirds-eli-cel/2026-09-14T17:47:35.000Zhttps://www.fdaweb.com/fda-panel-backs-novavax-covid-19-vaccine/2026-09-14T17:47:33.000Zhttps://www.fdaweb.com/cdrh-reg-advisor-silverstein-joins-private-sector/2026-09-14T17:47:32.000Zhttps://www.fdaweb.com/cgmp-other-violations-at-aire-master-of-america/2026-09-14T17:47:31.000Zhttps://www.fdaweb.com/shuren-advocates-for-more-regulatory-flexibility-post-covid/2026-09-14T17:47:30.000Zhttps://www.fdaweb.com/fda-approves-gsks-measles-vaccine/2026-09-14T17:47:29.000Zhttps://www.fdaweb.com/bristol-myers-withdraws-sbla-for-reblozyl/2026-09-14T17:47:28.000Zhttps://www.fdaweb.com/wa-state-court-backs-learned-intermediary-in-dtc-case/2026-09-14T17:47:27.000Zhttps://www.fdaweb.com/class-1-recall-on-respironics-ventilators-with-faulty-alarms/2026-09-14T17:47:26.000Zhttps://www.fdaweb.com/guide-on-device-meetings-user-fee-submissions-withdrawn/2026-09-14T17:47:25.000Zhttps://www.fdaweb.com/complete-response-letters-not-for-judicial-review-court/2026-09-14T17:47:24.000Zhttps://www.fdaweb.com/novavax-covid-vaccine-showed-myocarditis-safety-signal-fda/2026-09-14T17:47:23.000Zhttps://www.fdaweb.com/guide-on-device-electromagnetic-compatibility-considerations/2026-09-14T17:47:22.000Zhttps://www.fdaweb.com/electrical-stimulation-device-for-premature-ejaculation/2026-09-14T17:47:21.000Zhttps://www.fdaweb.com/troubled-lupin-hires-former-fda-nj-district-director/2026-09-14T17:47:20.000Zhttps://www.fdaweb.com/gao-calls-out-unfinished-fda-inspection-recommendations/2026-09-14T17:47:19.000Zhttps://www.fdaweb.com/senate-bipartisan-bill-on-device-cybersecurity/2026-09-14T17:47:18.000Zhttps://www.fdaweb.com/fda-extends-review-of-amylyxs-als-drug/2026-09-14T17:47:17.000Zhttps://www.fdaweb.com/new-apyx-re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ore-feedback-on-innovative-trials/2026-09-14T14:28:43.000Zhttps://www.fdaweb.com/rinvoq-shows-promise-in-arteritis-abbvie/2026-09-14T14:28:42.000Zhttps://www.fdaweb.com/philips-respironics-recalls-trilogy-evo-ventilators/2026-09-14T14:28:41.000Zhttps://www.fdaweb.com/data-show-long-term-shingrix-efficacy-gsk/2026-09-14T14:28:41.000Zhttps://www.fdaweb.com/fda-approves-lumisight-to-help-find-cancer/2026-09-14T14:28:40.000Zhttps://www.fdaweb.com/priority-review-voucher-to-orchard-therapeutics/2026-09-14T14:28:39.000Zhttps://www.fdaweb.com/new-pmi-form-explained/2026-09-14T14:28:38.000Zhttps://www.fdaweb.com/info-collection-on-drug-expedited-programs-2/2026-09-14T14:28:38.000Zhttps://www.fdaweb.com/scotus-wont-hear-false-labeling-case/2026-09-14T14:28:37.000Zhttps://www.fdaweb.com/phrma-changes-for-data-committee-guide/2026-09-14T14:28:36.000Zhttps://www.fdaweb.com/woodcock-plays-advisory-role-at-patient-nonprofit/2026-09-14T14:28:36.000Zhttps://www.fdaweb.com/alecensa-okd-for-alk-positive-lung-cancer/2026-09-14T14:28:35.000Zhttps://www.fdaweb.com/3rd-eugia-fda-483-this-year-so-far/2026-09-14T14:28:34.000Zhttps://www.fdaweb.com/its-official-oncopeptides-pepaxto-is-withdrawn/2026-09-14T14:28:33.000Zhttps://www.fdaweb.com/fda-reports-on-device-safety-innovation/2026-09-14T14:28:32.000Zhttps://www.fdaweb.com/fda-denies-generic-imodium-petition/2026-09-14T14:28:32.000Zhttps://www.fdaweb.com/boston-scientific-recalls-obsidio-embolic/2026-09-14T14:28:31.000Zhttps://www.fdaweb.com/fresenius-recall-infusion-pump-softeware/2026-09-14T14:28:30.000Zhttps://www.fdaweb.com/sen-cassidy-challenges-fda-on-cds-oversight/2026-09-14T14:28:30.000Zhttps://www.fdaweb.com/lilly-filing-nda-for-expanded-tirzepatide-use/2026-09-14T14:28:29.000Zhttps://www.fdaweb.com/restrictions-on-lutathera-anda-sought/2026-09-14T14:28:28.000Zhttps://www.fdaweb.com/soulaire-marketing-unapproved-device-fda/2026-09-14T14:28:27.000Zhttps://www.fdaweb.com/sun-pharma-hit-with-483-after-india-inspection/2026-09-14T14:28:27.000Zhttps://www.fdaweb.com/2-cgmp-violations-in-natco-pharma-inspection/2026-09-14T14:28:26.000Zhttps://www.fdaweb.com/ex-ceo-sentenced-over-phony-covid-test/2026-09-14T14:28:25.000Zhttps://www.fdaweb.com/clinical-trial-innovation-center-established/2026-09-14T14:28:25.000Zhttps://www.fdaweb.com/fda-warns-on-suspected-counterfeit-botox/2026-09-14T14:28:24.000Zhttps://www.fdaweb.com/xstim-spine-fusion-stimulator-approved/2026-09-14T14:28:23.000Zhttps://www.fdaweb.com/c-t-dream-co-cgmp-violations/2026-09-14T14:28:22.000Zhttps://www.fdaweb.com/cber-joining-lupus-research-consortium/2026-09-14T14:28:22.000Zhttps://www.fdaweb.com/new-cdrh-dataset-for-chemical-characterization/2026-09-14T14:28:21.000Zhttps://www.fdaweb.com/clinical-hold-on-neumora-study-in-brain-diseases/2026-09-14T14:28:20.000Zhttps://www.fdaweb.com/gsk-bla-accepted-for-meningococcal-vaccine/2026-09-14T14:28:20.000Zhttps://www.fdaweb.com/novartis-reports-favorable-data-on-kidney-drug/2026-09-14T14:28:19.000Zhttps://www.fdaweb.com/fda-clears-3d-printed-cranial-implant/2026-09-14T14:28:18.000Zhttps://www.fdaweb.com/orphan-status-for-ebola-like-vaccine/2026-09-14T14:28:17.000Zhttps://www.fdaweb.com/fda-inspection-hits-zydus-with-form-483/2026-09-14T14:28:17.000Zhttps://www.fdaweb.com/heartmate-pumps-recalled-due-to-obstructions/2026-09-14T14:28:16.000Zhttps://www.fdaweb.com/cder-launches-trial-innovation-center/2026-09-14T14:28:15.000Zhttps://www.fdaweb.com/sun-gets-oai-inspection-at-india-facility/2026-09-14T14:28:14.000Zhttps://www.fdaweb.com/fresenius-recalls-infusion-pump-software/2026-09-14T14:28:14.000Zhttps://www.fdaweb.com/panel-backs-minimal-residual-disease-endpoint/2026-09-14T14:28:13.000Zhttps://www.fdaweb.com/puretech-gets-fast-track-on-lyt-200/2026-09-14T14:28:12.000Zhttps://www.fdaweb.com/enlivex-mixed-results-of-sepsis-cell-therapy/2026-09-14T14:28:12.000Zhttps://www.fdaweb.com/ai-software-authorized-for-osteoporosis-screens/2026-09-14T14:28:11.000Zhttps://www.fdaweb.com/fda-updates-safety-labeling-for-envarsus-xr/2026-09-14T14:28:10.000Zhttps://www.fdaweb.com/ema-committee-dismisses-glp-1-suicidality-risk/2026-09-14T14:28:10.000Zhttps://www.fdaweb.com/9-applicants-chosen-for-drug-quality-evaluation/2026-09-14T14:28:09.000Zhttps://www.fdaweb.com/kemstro-not-withdrawn-due-to-safety-efficacy/2026-09-14T14:28:08.000Zhttps://www.fdaweb.com/oncolytics-wants-fda-meeting-on-pelareorep/2026-09-14T14:28:07.000Zhttps://www.fdaweb.com/vistaril-not-withdrawn-over-safety-efficacy/2026-09-14T14:28:07.000Zhttps://www.fdaweb.com/6-observations-in-cipla-fda-483/2026-09-14T14:28:06.000Zhttps://www.fdaweb.com/roche-alzheimers-test-is-breakthrough-device/2026-09-14T14:28:05.000Zhttps://www.fdaweb.com/fasenra-okd-for-pediatric-severe-asthma/2026-09-14T14:28:04.000Zhttps://www.fdaweb.com/neurovalens-anxiety-device-cleared/2026-09-14T14:28:03.000Zhttps://www.fdaweb.com/califf-defends-fda-role-in-patent-listings/2026-09-14T14:28:02.000Zhttps://www.fdaweb.com/drug-shortages-at-highest-leve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-study-guidance/2026-09-14T14:25:46.000Zhttps://www.fdaweb.com/iclusig-accelerated-approval-for-leukemia/2026-09-14T14:25:45.000Zhttps://www.fdaweb.com/senators-want-defense-drug-supply-security-update/2026-09-14T14:25:44.000Zhttps://www.fdaweb.com/fda-accepts-bla-resubmission-for-lymphir/2026-09-14T14:25:44.000Zhttps://www.fdaweb.com/changes-proposed-to-manufacturing-tech-draft/2026-09-14T14:25:43.000Zhttps://www.fdaweb.com/eugia-inspection-results-in-7-item-fda-483/2026-09-14T14:25:42.000Zhttps://www.fdaweb.com/gsk-reports-favorable-jemperli-phase-3-data/2026-09-14T14:25:42.000Zhttps://www.fdaweb.com/bayers-aliqopa-withdrawn-over-failed-confirmation/2026-09-14T14:25:41.000Zhttps://www.fdaweb.com/guidance-on-generic-drug-controlled-correspondence/2026-09-14T14:25:40.000Zhttps://www.fdaweb.com/sleepnet-recalls-sleep-apnea-masks/2026-09-14T14:25:39.000Zhttps://www.fdaweb.com/orchards-leukodystrophy-gene-therapy-okd/2026-09-14T14:25:39.000Zhttps://www.fdaweb.com/fda-cites-gmps-in-abeona-inspection/2026-09-14T14:25:38.000Zhttps://www.fdaweb.com/date-correction-in-alzheimers-guidance/2026-09-14T14:25:37.000Zhttps://www.fdaweb.com/guide-on-animal-drug-mfg-batches/2026-09-14T14:25:37.000Zhttps://www.fdaweb.com/biotronik-breakthrough-status-for-freesolve-device/2026-09-14T14:25:36.000Zhttps://www.fdaweb.com/cder-launches-inspections-web-page/2026-09-14T14:25:35.000Zhttps://www.fdaweb.com/generic-drug-controlled-correspondence-guidance/2026-09-14T14:25:34.000Zhttps://www.fdaweb.com/more-info-on-quality-manufacturing-maturity/2026-09-14T14:25:34.000Zhttps://www.fdaweb.com/fda-paper-on-ai-targets-4-focus-areas/2026-09-14T14:25:33.000Zhttps://www.fdaweb.com/draft-guidance-in-device-thermal-effects/2026-09-14T14:25:32.000Zhttps://www.fdaweb.com/device-q-submission-feedback-draft-guidance/2026-09-14T14:25:32.000Zhttps://www.fdaweb.com/medical-device-regs-technical-amendment/2026-09-14T14:25:31.000Zhttps://www.fdaweb.com/fda-guidance-on-device-thermal-effects/2026-09-14T14:25:30.000Zhttps://www.fdaweb.com/comments-on-advanced-mfg-tech-guide/2026-09-14T14:25:29.000Zhttps://www.fdaweb.com/updated-draft-q-submission-guidance/2026-09-14T14:25:29.000Zhttps://www.fdaweb.com/poseida-orphan-status-for-car-t-cell-therapy/2026-09-14T14:25:28.000Zhttps://www.fdaweb.com/medos-recalls-cerebase-da-guide-sheath/2026-09-14T14:25:27.000Zhttps://www.fdaweb.com/ortho-trivicta-hip-system-cleared/2026-09-14T14:25:27.000Zhttps://www.fdaweb.com/notice-corrected-on-flowtuss-nda-withdrawal/2026-09-14T14:25:26.000Zhttps://www.fdaweb.com/guide-on-safety-reporting-standards/2026-09-14T14:25:25.000Zhttps://www.fdaweb.com/damning-report-on-alzheimer-drug-tests-article/2026-09-14T14:25:24.000Zhttps://www.fdaweb.com/cassidy-wants-test-regulation-ideas/2026-09-14T14:25:23.000Zhttps://www.fdaweb.com/fda-approves-madrigal-fatty-liver-drug/2026-09-14T14:25:22.000Zhttps://www.fdaweb.com/advisors-to-weigh-imetelstat-benefits-risks/2026-09-14T14:25:21.000Zhttps://www.fdaweb.com/post-approval-safety-data-reporting-guide/2026-09-14T14:25:21.000Zhttps://www.fdaweb.com/odac-looking-at-increased-deaths-in-2-drugs/2026-09-14T14:25:20.000Zhttps://www.fdaweb.com/fda-budgets-to-expand-foreign-footprint/2026-09-14T14:25:19.000Zhttps://www.fdaweb.com/need-to-creatively-regulate-software-as-device-atty/2026-09-14T14:25:19.000Zhttps://www.fdaweb.com/petition-seeks-more-ozempic-mounjaro-trials/2026-09-14T14:25:18.000Zhttps://www.fdaweb.com/breakthrough-status-for-anxiety-disorder-drug/2026-09-14T14:25:17.000Zhttps://www.fdaweb.com/ensartinib-nda-accepted-for-lung-cancer/2026-09-14T14:25:16.000Zhttps://www.fdaweb.com/phrma-seeks-waivers-on-patient-medication-info/2026-09-14T14:25:16.000Zhttps://www.fdaweb.com/drug-supply-small-dispenser-info-collection-2/2026-09-14T14:25:15.000Zhttps://www.fdaweb.com/drug-supply-small-dispenser-info-collection/2026-09-14T14:25:14.000Zhttps://www.fdaweb.com/par-pharmaceutical-recalls-1-treprostinil-lot/2026-09-14T14:25:14.000Zhttps://www.fdaweb.com/nonprescription-drug-labeling-changes-draft-guide/2026-09-14T14:25:13.000Zhttps://www.fdaweb.com/draft-guide-on-device-cybersecurity/2026-09-14T14:25:12.000Zhttps://www.fdaweb.com/help-industry-with-bad-labs-post/2026-09-14T14:25:11.000Zhttps://www.fdaweb.com/pharmaceutical-science-advisory-panel-renewed/2026-09-14T14:25:11.000Zhttps://www.fdaweb.com/qs-mdr-issues-seen-in-exactech-inspection/2026-09-14T14:25:10.000Zhttps://www.fdaweb.com/false-or-misleading-senvelgo-claims-cvm/2026-09-14T14:25:09.000Zhttps://www.fdaweb.com/minor-drug-labeling-change-reporting-guide/2026-09-14T14:25:09.000Zhttps://www.fdaweb.com/cybersecurity-guidance-updates-proposed/2026-09-14T14:25:08.000Zhttps://www.fdaweb.com/digital-drug-marketing-workshop-themes/2026-09-14T14:25:07.000Zhttps://www.fdaweb.com/adcetris-positive-lymphoma-data-pfizer/2026-09-14T14:25:06.000Zhttps://www.fdaweb.com/most-mdrs-hit-device-function-issues-study/2026-09-14T14:25:06.000Zhttps://www.fdaweb.com/lexicon-refiling-nda-for-sotagliflozin-in-di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