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Moderna Covid-19 Vaccine Gets Fast Track

[ Price : $8.95]

FDA grants Moderna a fast track designation for its mRNA vaccine candidate (mRNA-1273) for Covid-19.

Multiple Violations at Nephron Pharmaceuticals

[ Price : $8.95]

FDA releases an FDA-483 with nine observations from an inspection at Nephron Sterile Compounding Center.

Court Backs FDA in PMRS Opioid Drug Case

[ Price : $8.95]

The DC Circuit Court of Appeals says FDA acted properly in denying a PMRS NDA for an opioid product that claimed abuse-deterrent p...

Applied Medical Python Embolectomy Recall Class 1

[ Price : $8.95]

FDA says an Applied Medical recall of three embolectomy and cleaning catheters is Class 1.

PhRMA Generally Supports Capacity Planning Method

[ Price : $8.95]

PhRMA says it generally supports the FDA capacity planning adjustment methodology for drug and biologic user fee programs.

Multiple Violations at Images Unlimited Products

[ Price : $8.95]

FDA warns Images Unlimited about multiple violations in its production and distribution of drugs and dietary supplements.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Fusion Health and Vitality and Images Unlimited Products.

Fusion Health Sold Unapproved Covid Products: FDA

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FDA warns Fusion Health and Vitality that it sold unapproved, misbranded drug products intended to treat Covid-19.

FDA Updates Purple Book on Biologics

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FDA updates its Purple Book: Database of FDA-Licensed Biological Products to add all FDA-licensed, biological products regulated b...

FDA, CDC Working on Plan to Reopen Inspections

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FDA commissioner Stephen Hahn says his agency is working with the CDC on a science-driven process to restart on-site surveillance ...