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FDA Proposed Rule to Improve FOIA Process

[ Price : $8.95]

Federal Register proposed rule: FDA proposes to amend current regulations to incorporate changes made to the Freedom of Informatio...

Science Board to Hear CVM Antibiotic Resistance Response

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Federal Register notice: FDA announces a 10/22 public advisory committee meeting of its Science Board. that will hear a response f...

PharmD Solutions Recalls Compounded Drugs

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Pharm D Solutions recalls all sterile compounded drug products within expiry due to concerns that practices at the pharmacy have t...

Proposed Rule on Device Electronic Submissions

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Federal Register proposed rule: FDA proposes to amend requirements for medical device premarket submissions to remove paper and mu...

Staar Surgical Collamer Lens OKd for Myopic Astigmatism

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FDA approves a Staar Surgical PMA supplement for the Visian Toric Implantable Collamer Lens for the correction of myopia with asti...

Unexpected Impurity in Some Valsartan Products

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FDA says a new, unexpected impurity has been found in some lots of recalled drug products containing the active ingredient valsart...

Gottlieb Outlines New Diagnostics Regulatory Framework

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FDA commissioner Scott Gottlieb outlines a new regulatory framework he has suggested to Congress for diagnostic tests.

Yuki Gosei Kogyo Inspection Observations

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FDA releases the FDA-483 with nine observations from an inspection at Japans Yuki Gosei Kogyo API manufacturer.

2 Voluntary Consensus Standards Guidances

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FDA publishes a draft guidance and a finalized guidance on voluntary consensus standards for medical devices.

5 Observations from Cook Pharmica Inspection

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FDA issues an FDA-483 with five inspection observations at Cook Pharmica.