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TXT Consultants Submit Draft AAV Guidance to FDA [2703 Words] [ Price : $8.95]
Dark Horse Consulting Group submits a draft gene therapy guidance to FDA developed by former CBER staffer Donald Fink in consultation with other experts.
05/17/2022
 
 
TXT Improving Trial Representation Book [2814 Words] [ Price : $8.95]
The National Academies produces a book on improving representation for women and minorities in clinical trials and research.
05/17/2022
 
 
TXT Apollo Care FDA-483 [2692 Words] [ Price : $8.95]
FDA releases the FDA-483 with five observations from an inspection at the Columbia, MO-based Apollo Care outsourcing facility.
05/17/2022
 
 
TXT Guide on Generic User Fee Assessments [84 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.”
05/17/2022
 
 
TXT Senate Bill to Restore FDA Orphan Drug Interpretation [216 Words] [ Price : $8.95]
Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduce legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which addresses a 2021 court decision that adversely impacts how FDA interprets orphan drug exclusivity.
05/17/2022
 
 
TXT Senate Draft User Fee Bill Sets IVD Regulation [401 Words] [ Price : $8.95]
The Senate HELP Committee releases a discussion draft of a bill that would reauthorize user fee programs for another five years and enhance certain other program areas, like the regulation of diagnostic tests and stronger oversight of cosmetics and dietary supplements.
05/17/2022
 
 
TXT Clinical Hold Lifted on Gilead HIV Therapy [242 Words] [ Price : $8.95]
FDA removes a clinical hold on Gilead Sciences’ injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis.
05/16/2022
 
 
TXT FDA Hits Lupin’s Novel Labs with 13-item 483 [271 Words] [ Price : $8.95]
A March FDA inspection of Novel Laboratories (dba Lupin Somerset) leads to a 13-item FDA Form-483 that cites significant and repeat GMP deficiencies.
05/16/2022
 
 
TXT FDA Rejects EUA for Fluvoxamine in Covid [246 Words] [ Price : $8.95]
FDA rejects an emergency use authorization request filed by University of Minnesota Medical School infectious disease physician David Boulware and other researchers to allow the use of generic drug fluvoxamine maleate for outpatient treatment of Covid-infected adults.
05/16/2022
 
 
TXT Travere Therapeutics NDA Accepted for Sparsentan [218 Words] [ Price : $8.95]
FDA accepts for priority review a Travere Therapeutics NDA for sparsentan and its use in treating IgA nephropathy.
05/16/2022
 
 
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