FDA Policy/General

Latest Federal Register Notices

Former Able Labs Quality Manager Debarred
Federal Register notice: FDA denies a request for a hearing from Dilip Patel and is issuing an order to debar Patel for five years from providing services in any capacity to a person that has an approved or pending drug product application. 09/28/2018

FDA Reclassifies Single-use Female Condoms
Federal Register notice: FDA issues a final order to reclassify single- use female condoms, renaming the device to “single-use internal condom,” a postamendments Class 3 device into Class 2 (special controls) subject to premarket notification (510(k)). 09/28/2018

Comments Reopened on Coronary Stent Guides
Federal Register notice: FDA reopens the comment period related to two draft guidance documents on coronary drug-eluting stents. 09/27/2018

FDA Withdraws Approval for 7 ANDAs
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency in writing that the drug products were no longer marketed. 09/27/2018

Draft Guide on Compounding Insanitary Conditions
Federal Register notice: FDA makes available a draft guidance entitled “Insanitary Conditions at Compounding Facilities.” 09/27/2018

Guide on Radiopharmaceuticals from Outsourcing Facilities
Federal Register notice: FDA makes available a final guidance entitled “Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.” 09/27/2018

Countermeasure Priority Review Voucher Fee $2.5 Million
Federal Register notice: FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2019 — $2,457,140. 09/27/2018

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome