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Human Drugs

Revise Anti-Infective Drug Development Outcomes: Study

Researchers call on FDA to update guidances on endpoints for developing anti-infective drugs.

Human Drugs

Trump Changing Drug Price Plan

The Hill reports the Trump administration is proposing to lower some drug prices by ensuring that prices in this country are lower than comparable pri...

Human Drugs

FDA Making Less Use of Advisory Committees: Analysis

Eye on FDA notes a reduction in the number of drug-related advisory committee meetings this year and whether this can be seen as less transparency in ...

Human Drugs

Potential Dietary Supplement Statutory Changes

FDA principal deputy commissioner Lloyd Schiller says the agency is looking at changes to the Dietary Supplement Health and Education Act to enable it...

Human Drugs

FDA Clinical Hold for Solid Biosciences Duchenne Trial

FDA places a Solid Biosciences Phase 1/2 trial of its SGT-001 Duchenne muscular dystrophy drug on clinical hold.

Federal Register

Info Collection on Combo Product Jurisdiction

Federal Register notice: FDA sends to OMB an information collection extension for Product Jurisdiction: Assignment of Agency Component for Review of P...

Human Drugs

CGMP Deviations Found in Mylan Unit 8

FDA warns Mylan about significant deviations from CGMP requirements for active pharmaceutical ingredients at its Unit 8 in India.

Human Drugs

Cadila Healthcare CGMP Violations

FDA warns Indias Cadila Healthcare about CGMP violations in its manufacturing of finished pharmaceuticals.

Medical Devices

BD PMA Supplement to Expand HPV Assay

Becton Dickinson files a PMA supplement for an expanded version of its BD Onclarity HPV Assay.

Medical Devices

FDA OKs Hologics 3DQuorum Imaging Technology

FDA approves a Hologic PMA for its 3DQuorum Imaging Technology for use with the companys Clarity HD high resolution imaging technology to reduce tomos...