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Human Drugs

Radiolabeled Mass Balance Study Comments

Four stakeholders request clarification of parts of an FDA draft guidance on clinical pharmacology considerations for human radiolabeled mass balance ...

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Human Drugs

Comments on Drug Shortage Risk Guidance

Two stakeholders request changes to an FDA draft guidance on risk management plans to mitigate the potential for drug shortages.

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Medical Devices

Guide on Contact Lens Hydrogen Peroxide Products

FDA posts a draft guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations Premarket Notification (510(...

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Federal Register

Makena NDA Withdrawal Hearing 10/17-19

Federal Register notice: FDA grants a 10/17-19 hearing request to review and vote on whether agency approval for Covis Makena (hydroxyprogesterone cap...

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Federal Register

30 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws approval of 30 NDAs from multiple applicants after they notified the agency that the products are no longer mar...

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Medical Devices

FDA OKs OTC Hearing Aids

FDA authorizes personal sound amplification products as over-the-counter hearing aids for some consumers.

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Medical Devices

Replacement Reagent Instrument Family Policy Guidance

FDA publishes an updated guidance on replacement reagent and instrument family policy for in vitro diagnostic devices.

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Human Drugs

CGMP Violations at Verde Cosmetic Labs

FDA warns Northridge, CA-based Verde Cosmetic Labs about CGMP violations in its production of finished drugs.

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Human Drugs

NIH Did Not Ensure Trial Reporting: OIG

The HHS Office of Inspector General says the National Institutes of Health failed to enforce federal requirements that clinical trial results be timel...

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Human Drugs

Drug Inspections at Operational Levels: Throckmorton

Attorney Douglas Farquhar says FDA speakers at a GMP conference indicated that domestic drug facility inspections are back at operational levels.