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AAM Ideas on DoJ, FTC Merger Enforcement

[ Price : $8.95]

The Association for Accessible Medicines gives its views on Department of Justice and Federal Trade Commission efforts to moderniz...

FDA, Industry Agree on MDUFA 5 Reauthorization

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FDA says it has reached an agreement with representatives of the medical device industry on the MDUFA 5 reauthorization provisions...

Quantum Surgical Liver Cancer Robot Cleared

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FDA clears a Quantum Surgical 510(K) for its Epione, described as a robotic-assisted device designed to plan, target, deliver and ...

FDA Announces EUA for Lillys Bebtelovimab

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Federal Register notice: FDA announces an Emergency Use Authorization issuance to Eli Lilly for bebtelovimab and its use in treati...

FDA Ophthalmic Product Guidance Mandated by Court

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FDA publishes an immediately effective guidance to tell how it is handling ophthalmic dispensers packaged with their drugs in ligh...

Inactive Ingredient Max Daily Exposure Addition

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Federal Register notice: FDA establishes a docket to solicit comments that will assist the agency in determining how best to prior...

Drug Supply Guidance Notice Corrected

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Federal Register notice: FDA corrects a 3/10 notice on a draft guidance entitled Verification Systems Under the Drug Supply Chain ...

Panel Meeting to Discuss Covid Booster Vaccines

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FDA announces a 4/6 virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations f...

FDA-483 on Cadila Healthcare Inspection Posted

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FDA posts a Cadila Healthcare (a Zydus Lifesciences company) Form FDA-483 that provides details of GMP violations identified in a ...

Drug Supply Guidance Notice Corrected

[ Price : $8.95]

Federal Register notice: FDA corrects a 3/10 notice on a draft guidance entitled Verification Systems Under the Drug Supply Chain ...