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Multiple CGMP Violations at Colorful Products

[ Price : $8.95]

FDA warns Newbury Park, CA-based Colorful Products about CGMP violations in its manufacturing of over-the-counter topical drug pro...

API Deviations at Specialty Process Labs

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FDA warns Phoenix, AZ-based Specialty Process Labs about deviations from CGMP requirements for active pharmaceutical ingredients.

FDA Authorizes Kids Pfizer Covid Vaccine Booster

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FDA authorizes a single booster shot of the Pfizer/BioNTech Covid-19 vaccine in children aged 5-11.

FDA Accepts scPharmaceuticals NDA for Furoscix

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FDA accepts for review an scPharmaceuticals NDA for Furoscix (furosemide) delivered through an on-body infusor for treating conges...

Guide on Container Labeling Safety Considerations

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Federal Register notice: FDA makes available a final guidance entitled Safety Considerations for Container Labels and Carton Label...

Consultants Submit Draft AAV Guidance to FDA

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Dark Horse Consulting Group submits a draft gene therapy guidance to FDA developed by former CBER staffer Donald Fink in consultat...

Improving Trial Representation Book

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The National Academies produces a book on improving representation for women and minorities in clinical trials and research.

Apollo Care FDA-483

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FDA releases the FDA-483 with five observations from an inspection at the Columbia, MO-based Apollo Care outsourcing facility.

Guide on Generic User Fee Assessments

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Federal Register notice: FDA makes available a final guidance entitled Assessing User Fees Under the Generic Drug User Fee Amendme...

Senate Bill to Restore FDA Orphan Drug Interpretation

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Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) introduce legislation entitled the Retaining Access and Restoring Exclusivit...