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FDA publishes an immediately effective guidance on emergency use authorizations for monkeypox diagnostic tests.[ 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 ...[ Price : $8.95]
FDA issues a safety alert to warn about potential clip lock malfunctions with Abbotts MitraClip Delivery Systems.[ Price : $8.95]
FDA approves a Revance Therapeutics BLA for injectable Daxxify (daxibotulinumtoxinA-lanm) for temporarily improving moderate-to-se...[ Price : $8.95]
FDA issues a draft guidance intended to improve the consistency of labeling for nonprescription drugs.[ Price : $8.95]
In an unusual second advisory committee meeting in six months, panel members reverse their March vote and recommend approval for A...[ Price : $8.95]
FDA releases a Form FDA-483 with seven observations from an inspection at Koreas Hugel drug substance and drug product manufacturi...[ Price : $8.95]
FDA publishes a draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biologics...