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Kiniksa sBLA for Rilonacept in Recurrent Pericarditis

[ Price : $8.95]

FDA accepts for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis.

Guide on Biosimilarity and Interchangeability

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As...

Cross Labeling Oncology Drugs Guidance

[ Price : $8.95]

Federal Register notice: FDA announces the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in...

J&J Subsidiary Pays $10 Million on Drug/Device Promo Violations

[ Price : $8.95]

Johnson & Johnson subsidiary Medical Device Business Services agrees to pay $10 million to settle allegations under the False Clai...

Covid-19 Device EUA Listing Updated

[ Price : $8.95]

Federal Register notice: FDA updates its ongoing listing of issued and reissued Emergency Use Authorizations for medical devices r...

Drug Interaction Study Guide for Contraceptives

[ Price : $8.95]

FDA issues a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.

Pfizer/BioNTech Submit EUA for Covid-19 Vaccine

[ Price : $8.95]

Pfizer and BioNTech file an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 dat...

Fresenius Kabi Recalls 1 Lot of Dexmedetomidine

[ Price : $8.95]

Fresenius Kabi recalls a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vi...

FDA Adds More ANDA-specific Bioequivalence Guidances

[ Price : $8.95]

Federal Register notice: FDA posts 30 additional draft and revised draft product-specific guidances on the design of bioequivalenc...

FDA Debarment Order Against Ex-Insys Manager

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Richard M. Simon from providing services in any capacity to a p...