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FDA Emergency Monkeypox Test Guidance

[ Price : $8.95]

FDA publishes an immediately effective guidance on emergency use authorizations for monkeypox diagnostic tests.

Panacea Biotec Inspection is OAI

[ Price : $8.95]

Indias Panacea Biotec says it is working with FDA to close a recent inspection that had eight observations and an Official Action ...

Safety Alert on Abbotts MitraClip Delivery Systems

[ Price : $8.95]

FDA issues a safety alert to warn about potential clip lock malfunctions with Abbotts MitraClip Delivery Systems.

FDA Approves Daxxify for Frown Lines

[ Price : $8.95]

FDA approves a Revance Therapeutics BLA for injectable Daxxify (daxibotulinumtoxinA-lanm) for temporarily improving moderate-to-se...

Nonprescription Drug Label Guidance

[ Price : $8.95]

FDA issues a draft guidance intended to improve the consistency of labeling for nonprescription drugs.

2nd Time a Charm in ALS Drug Panel Vote

[ Price : $8.95]

In an unusual second advisory committee meeting in six months, panel members reverse their March vote and recommend approval for A...

7 Observations in Koreas Hugel FDA-483

[ Price : $8.95]

FDA releases a Form FDA-483 with seven observations from an inspection at Koreas Hugel drug substance and drug product manufacturi...

Pharmacology Pediatric Studies Guidance

[ Price : $8.95]

FDA publishes a draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biologics...

Philips Respironics Recalls 17 Million Airway Masks

[ Price : $8.95]

Philips Respironics recalls 17 million masks used with bilevel positive airway pressure machines and continuous positive airway pr...

Panel to Discuss EUA for Covid-19 Therapy

[ Price : $8.95]

Federal Register notice: FDA announces a 10/6 advisory committee meeting to discuss a Veru Inc. request for an emergency use autho...