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TXT Breakthrough for Limaca Endoscopic Ultrasound Biopsy [257 Words] [ Price : $8.95]
FDA grants Limaca Medical a breakthrough device designation for its Precision-GI endoscopic ultrasound biopsy product.
05/03/2022
 
 
TXT 3 ICSR Electronic Transmission Guidances [2771 Words] [ Price : $8.95]
FDA publishes 3 guidances on implementing an International Council on Harmonization guidance on electronic submission of individual case safety reports.
05/03/2022
 
 
TXT Lasik Injury Advocate Urges Action on Misleading Ads [586 Words] [ Price : $8.95]
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.”
05/03/2022
 
 
TXT Covid-19 and Annual Vaccinations is the New Normal: FDA [527 Words] [ Price : $8.95]
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.”
05/03/2022
 
 
TXT Advisory Panel to Vote on Nuplazid Resubmission [148 Words] [ Price : $8.95]
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.
05/03/2022
 
 
TXT CGMP Deviations at Miami University Contract Lab [2789 Words] [ Price : $8.95]
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.
05/03/2022
 
 
TXT Info Collection on Device Administrative Detention [88 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “Administrative Detention and Banned Medical Devices.”
05/03/2022
 
 
TXT FDA Rejects HutchMed NDA Over China Trial Data [583 Words] [ Price : $8.95]
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.
05/02/2022
 
 
TXT No FDA Action Against Accused Researchers [459 Words] [ Price : $8.95]
FDA denies a Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minneapolis, MN, who “repeatedly and deliberately violated agency regulations intended to protect human subjects.”
05/02/2022
 
 
TXT Regeneron Awarded Priority Review Voucher [84 Words] [ Price : $8.95]
Federal Register notice: FDA issues Regeneron Pharmaceuticals a priority review voucher under its material threat medical countermeasure product program.
05/02/2022
 
 
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