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TXT Hulu Series on Oxycontin Hits Hard, Goes Easy on FDA [3285 Words] [ Price : $8.95]
Hulu launches an eight-part series on the Oxycontin epidemic that graphically lambastes Purdue Pharma but soft-pedals FDAs enabling role.
10/27/2021
 
 
TXT Routine Vaccine Inspections May be Challenge: GAO [2736 Words] [ Price : $8.95]
The Government Accountability Office says FDA may be challenged in resuming routine surveillance inspections of vaccine and allergenic manufacturing facilities.
10/27/2021
 
 
TXT Yale Working with FDA on Trial Diversity [2633 Words] [ Price : $8.95]
FDA contracts with the Yale School of Medicine to promote clinical trial awareness and access to underrepresented minorities.
10/27/2021
 
 
TXT FDA Breast Implant Safety Actions [2676 Words] [ Price : $8.95]
FDA says it has taken three new actions to strengthen the risk communication about breast implants and help consumers to make informed decisions.
10/27/2021
 
 
TXT Panel to Review Merck Covid Drug [77 Words] [ Price : $8.95]
Federal Register notice: FDA announces an 11/30 Antimicrobial Drugs Advisory Committee meeting to review a Merck Emergency Use Authorization request for molnupiravir oral capsules, indicated for treating mild to moderate Covid-19.
10/27/2021
 
 
TXT CDRH Guidance Document Plans for FY 2022 [85 Words] [ Price : $8.95]
Federal Register notice: FDA announces the Web site location where it will post two lists of guidance documents that CDRH intends to publish in fiscal year 2022.
10/27/2021
 
 
TXT FDA, Others Working on Rare Disease Gene Therapies [2705 Words] [ Price : $8.95]
FDA is joining with 16 other organizations to increase effective gene therapies for rare diseases.
10/27/2021
 
 
TXT BIMO Inspectors Learn to Rely on Remote Assessments [640 Words] [ Price : $8.95]
CDER Office of Compliance director Don Ashley tells the Pharmaceutical Quality Symposium that during the Covid-10 pandemic, more than 70 bioresearch monitoring remote regulatory assessments have been conducted in lieu of physical FDA inspections to verify the clinical data that support regulatory applications.
10/27/2021
 
 
TXT CDRH Lists FY 2022 Proposed Guidances [2658 Words] [ Price : $8.95]
FDA publishes two lists of final and draft guidance topics for FY 2022 and a list of final guidances from four years for comment on whether they should be revised or withdrawn.
10/26/2021
 
 
TXT Comments on Draft PD Cancer Treatment Guidance [2795 Words] [ Price : $8.95]
Five drug companies comment on an FDA draft guidance on a cancer antibody treatment dosing regimen.
10/26/2021
 
 
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