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Medical Devices

Cotton Introduces Bill Targeting Chinese-Made Medical Devices

Sen. Tom Cotton (R-AR) introduces a bill that would require FDA to review and potentially recall Chinese-manufactured networked medical devices deemed...

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Human Drugs

CeleCor Completes NDA Submission for Heart Attack Drug

CeleCor Therapeutics says it has submitted an NDA for Disaggpro (zalunfiban), an investigational treatment for ST-segment elevation myocardial infarct...

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Human Drugs

Drug Quality Assurance Inspections Up in 2025

The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.

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Human Drugs

FDA Progressing Toward Replacing Animal Testing :Study

A newly published commentary in the journal Stem Cell Research & Therapy says FDAs efforts to reduce reliance on animal testing is driving a fundament...

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FDA General

Administration Weighs White House Aide for FDA Top Post

The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.

Biologics

JAMA Publishes Previously Blocked Covid-19 Vaccine Study

JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control an...

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FDA FY 2027 Appropriation Report Analyzed

Eight Hyman, Phelps & McNamara attorneys analyze a House Appropriations Committee report that explains its rationale and expectations for the FY 2027 ...

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Human Drugs

FTC Weighs in Against J&J in Stelara Monopoly Case

The Federal Trade Commission files an amicus brief supporting plaintiffs in an antitrust lawsuit accusing Johnson & Johnson of unlawfully maintaining ...

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Human Drugs

FDA Details Standardized Approach to Drug Safety Signal Detection

A new CDER Office of New Drugs webinar discusses the development and use of OND Custom Medical Queries to identify potential safety signals during rev...

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Medical Devices

Require IDE for Venas MicroAngioscope: Petition

Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena MicroAngioscope and take other steps to determine if...