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FDA Proposes 2nd Section 518(b) Order for Philips
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| FDA proposes issuing a second Section 518(b) order against Philips Respironics, this time to require the company to submit a plan to repair, replace, or refund recalled air pressure devices. |
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05/03/2022
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Confusion Over RWD and RWE: Perspective
[2730 Words]
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| Two CDER executives discuss misconceptions that remain about the meaning and use of real-world data and real-world evidence. |
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05/03/2022
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3 ICSR Electronic Transmission Guidances
[2771 Words]
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| FDA publishes 3 guidances on implementing an International Council on Harmonization guidance on electronic submission of individual case safety reports. |
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05/03/2022
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Lasik Injury Advocate Urges Action on Misleading Ads
[586 Words]
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| Vision Advocacy president Paula Cofer writes FDA commissioner Robert Califf urging regulatory action against refractive eye surgery providers who have a “long history of false, misleading advertising.” |
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05/03/2022
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Covid-19 and Annual Vaccinations is the New Normal: FDA
[527 Words]
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| Writing in a 5/2 online JAMA viewpoint, senior FDA officials prepare the agency and the public to accept that Covid-19 infections and upcoming seasonal vaccines are, just like influenza vaccines, the “new normal.” |
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05/03/2022
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Advisory Panel to Vote on Nuplazid Resubmission
[148 Words]
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| Federal Register notice: FDA announces a 6/17 Psychopharmacologic Drugs Advisory Committee meeting to vote on an Acadia Pharmaceuticals resubmitted supplemental NDA for a new indication for Nuplazid (pimavanserin) — treating hallucinations and delusions associated with Alzheimer’s disease psychosis. |
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05/03/2022
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CGMP Deviations at Miami University Contract Lab
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| FDA warns the Oxford, OH-based Miami University Department of Chemistry and Biochemistry contract testing laboratory about CGMP deviations in its testing of active pharmaceutical ingredients. |
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05/03/2022
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FDA Rejects HutchMed NDA Over China Trial Data
[583 Words]
[ Price : $8.95]
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| FDA sends HutchMed a complete response letter on its NDA for surufatinib, indicated for treating pancreatic and extra-pancreatic neuroendocrine tumors, and recommends the company conduct a multi-regional clinical trial to support the China Phase 3 data in the submission. |
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05/02/2022
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