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Optikem CGMP Violations Cited

[ Price : $8.95]

FDA warns Denver, CO-based Optikem about CGMP violations in its production of finished drugs.

CBER Updates 2024 Guidance Agenda

[ Price : $8.95]

CBER publishes an updated 2024 guidance agenda with 20 listings.

Elevar Resubmitting Cancer Drug NDA

[ Price : $8.95]

Elevar Therapeutics says that after a meeting with FDA it is ready to resubmit its NDA for rivoceranib in combination with camreli...

Obsidian Gets Fast Track for OBX-115

[ Price : $8.95]

FDA grants Obsidian Therapeutics a fast track designation for OBX-115, a T cell immunotherapy in combination with a pharmacologica...

EUA for CDC Monkeypox Diagnostic

[ Price : $8.95]

Federal Register notice: FDA grants an Emergency Use Authorization to the U.S. Centers for Disease Control and Prevention for its ...

EUA for Monkeypox Home Collection Kit

[ Price : $8.95]

FDA grants Laboratory Corp. of America an Emergency Use Authorization for the Labcorp Monkeypox PCR Test Home Collection Kit.

Info Collection on Device Reclassification Petitions

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Reclassification Petitions for Medical...

Philips Recalls Sense XL Torso MRI Coils

[ Price : $8.95]

Philips North America recalls its Sense XL Torso (1.5T and 3.0T) MRI coils to update use instructions due to a potential issue whe...

Groups Want Changes in Drug Labeling Guidance

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Two drug company associations recommend changes to an FDA draft guidance on the content and format of labeling statements of ingre...

Magellan Guilty Plea Over Misbranded Devices

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Magellan Diagnostics pleads guilty in federal court to criminal charges arising from its concealment of a device malfunction that ...