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TXT Multiple CGMP Violations at Colorful Products [2859 Words] [ Price : $8.95]
FDA warns Newbury Park, CA-based Colorful Products about CGMP violations in its manufacturing of over-the-counter topical drug products and hand sanitizers.
05/17/2022
 
 
TXT API Deviations at Specialty Process Labs [2871 Words] [ Price : $8.95]
FDA warns Phoenix, AZ-based Specialty Process Labs about deviations from CGMP requirements for active pharmaceutical ingredients.
05/17/2022
 
 
TXT FDA Authorizes Kids’ Pfizer Covid Vaccine Booster [2646 Words] [ Price : $8.95]
FDA authorizes a single booster shot of the Pfizer/BioNTech Covid-19 vaccine in children aged 5-11.
05/17/2022
 
 
TXT FDA Accepts scPharmaceuticals NDA for Furoscix [127 Words] [ Price : $8.95]
FDA accepts for review an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating congestion in patients with worsening heart failure.
05/17/2022
 
 
TXT Guide on Container Labeling Safety Considerations [122 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”
05/17/2022
 
 
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
 
 
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