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Gottlieb Touts Digital Health Approach

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FDA commissioner Scott Gottlieb explains the need for a new Center of Excellence for Digital Health.

FDA Proposes Special 510(k) Update, Clarification

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FDA solicits comments on a draft guidance to update and clarify the Special 510(k) program for some medical devices.

Additional FDA Drug Compounding Research

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FDA announces new and expanded research efforts into compounded drugs.

Comments Reopened on Coronary Stent Guides

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Federal Register notice: FDA reopens the comment period related to two draft guidance documents on coronary drug-eluting stents.

FDA Withdraws Approval for 7 ANDAs

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Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency in writing ...

Draft Guide on Compounding Insanitary Conditions

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Federal Register notice: FDA makes available a draft guidance entitled Insanitary Conditions at Compounding Facilities.

Guide on Radiopharmaceuticals from Outsourcing Facilities

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Federal Register notice: FDA makes available a final guidance entitled Compounding and Repackaging of Radiopharmaceuticals by Outs...

Countermeasure Priority Review Voucher Fee $2.5 Million

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Federal Register notice: FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for...

FDA Asks Labeling Change for Pen Needles

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FDA asks pen needle manufacturers to add a label Warning regarding proper use of the devices.

Sun Pharmaceutical FDA-483

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FDA releases the FDA-483 with two observations from a September inspection at the Sun Pharmaceutical facility in Punjab, India.