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Verax Asks FDA Not to Take Arbitrary Action

[ Price : $8.95]

Verax Biomedical calls on FDA not to take actions that would be considered arbitrary and capricious if unsupported by additional s...

Regenerative Therapies Outcome Measures Needed: Report

[ Price : $8.95]

The Alliance for Cell Therapy Now calls on FDA and other agencies to act to measure outcomes related to regenerative cell therapie...

Vabomeres Regulatory Review Period Determined

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Rempex Pharmaceuticals Vabo...

Info Collection on Minor Use/Species Drugs

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Reporting Associated With Designated New Animal ...

CGMP Violations Found in Teligent Inspection

[ Price : $8.95]

FDA warns Teligent Pharma about CGMP and Field Alert Report violations in its manufacturing of finished pharmaceuticals.

OHM Inspection Finds CGMP Issues

[ Price : $8.95]

FDA warns OHM Pharma about CGMP and other violations in its manufacturing of finished pharmaceuticals.

OrthoGrid Systems PhantomMSK Trauma Cleared

[ Price : $8.95]

FDA clears an OrthoGrid Systems 510(k) for its application PhantomMSK Trauma for use in orthopedic surgery.

Advance Notice, Staffing Still Harm Foreign Inspections: GAO

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New Government Accountability Office findings on FDAs foreign inspection program acknowledge improvements pointing up persistent r...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes OHM Pharma and Teligent Pharma.

Draft Guidance Hemorrhoid Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Development of Locally Applied Corticosteroid Products for ...