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Biologics

Stakeholder Comments on Cell, Gene Guidance

Three stakeholders recommend changes to an FDA draft guidance on human- and animal-derived materials in cell and gene therapeutic materials.

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Human Drugs

FDA Publishes ICH Bioequivalence Guidance

FDA publishes an International Council on Harmonization guidance on bioequivalence studies for immediate-release solid oral dosage forms.

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Medical Devices

FDA Clears Life Spine Sacroiliac Fixation Device

FDA clears a Life Spine 510(k) for its ARx SAI (sacral alar iliac) Spinal Fixation System.

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Human Drugs

FDA May Allow Novel Carve-Ins: Attorneys

Two Axinn attorneys say FDA may be signaling more flexibility in considering novel Section viii carve-in statements in ANDAs.

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Federal Register

Medical Device User Fee Rates

Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.

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Human Drugs

Prescription Drug User Fee Rates Set

Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2025.

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Medical Devices

Amco Illegally Selling AED Batteries: FDA

FDA warns Brooklyn, NY-based Amco International Manufacturing & Design about illegally manufacturing and distributing adulterated automated external d...

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Human Drugs

OSE Involved in 55 Novel Drug Approvals

The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic approvals in 2023.

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Human Drugs

Vertex NDA for Pain Drug Accepted for Review

FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pa...

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Federal Register

Generic Drug User Fee Rates for FY 2025

Federal Register notice: FDA releases fiscal year 2025 rates for generic drug user fees.