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UCS Surveying State of Science Under Biden

[ Price : $8.95]

The Union of Concerned Scientists says it will be asking scientists in seven federal agencies to describe the state of science in ...

FDA Breast Implant Cancer Alert

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FDA says its monitoring of breast implants has detected some cases of squamous cell carcinoma and various lymphomas in the scar ti...

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

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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

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

FDA Approves Daxxify for Frown Lines

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

Nonprescription Drug Label Guidance

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FDA issues a draft guidance intended to improve the consistency of labeling for nonprescription drugs.

2nd Time a Charm in ALS Drug Panel Vote

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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

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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

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FDA publishes a draft guidance on general clinical pharmacology considerations for pediatric studies of drugs, including biologics...