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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Acu-International Supplies, Alere, Avon, Bioque Technologies, CellTex Therapeuti...

Advisors Back NPS Gattex for Short Bowel Syndrome

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Members of FDAs Gastrointestinal Drugs Advisory Committee recommend the agency approve NPS Gattex for adults with short bowel synd...

High Court Brushes Off Warning Letter Case

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The U.S. Supreme Court passes on a Warning Letter case and whether such communications are final agency actions and reviewable in ...

Celltex Warning Letter Up Regulates Cell Product

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An FDA Warning Letter lays out the basis for the agencys recent determination that Celltex Therapeutics stem cell product is subje...

CGMP Issues Found in Stat Rx Facility

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FDAs Atlanta District Office warns Stat Rx about CGMP violations in its drug repackaging/manufacturing facility.

FDA Pulls Texas IRB New Study OKs

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FDA warns Texas Applied Biomedical Services about continuing violations of IRB regulations and withholds approval of all new studi...

Inspection at DMC Finds Quality System Problems

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FDA warns DMC Medical Technology and Manufacturing Co. about Quality System Regulation violations in its manufacturing facility in...

CDRH eCopy Submissions Guidance

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A draft guidance outlines CDRHs electronic submission requirements mandated by the recently enacted Safety and Innovation Act.

Guidances on 510(k) and PMA Review Clock Actions Out

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FDA issues guidances on MDUFA 3 performance goals for PMAs and 510(k)s.

FDA, ArQule Reach SPA Agreement on Tivantinib

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FDA and ArQule reach agreement on a Special Protocol Assessment for the design of a pivotal Phase 3 trial involving tivantinib in ...