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Drug Quality Assurance Inspections Up in 2025

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

FDA Progressing Toward Replacing Animal Testing :Study

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

Antibody Impurity Guidance Needs Specificity: Comments

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Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.

Stakeholders Comment on AI-Enabled Trial Pilot

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Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.

Administration Weighs White House Aide for FDA Top Post

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

JAMA Publishes Previously Blocked Covid-19 Vaccine Study

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

FDA FY 2027 Appropriation Report Analyzed

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Eight Hyman, Phelps & McNamara attorneys analyze a House Appropriations Committee report that explains its rationale and expectati...

FTC Weighs in Against J&J in Stelara Monopoly Case

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

FDA Details Standardized Approach to Drug Safety Signal Detection

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

Require IDE for Venas MicroAngioscope: Petition

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