FDA Policy/General

Latest Federal Register Notices

Regulatory Review Period Determined for Uromedica’s Proact
Federal Register notice: FDA determines that the regulatory review period for Uromedica’s Proact Adjustable Continence Therapy For Men was 3,892 days. 01/12/2018

Comments Extended for Guide on Submitting ANDA/505(b)(2)
Federal Register notice: FDA reopens the comment period until 2/12 on a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” 01/12/2018

Comments Extended on Orphan Drug Guidance
Federal Register notice: FDA extends the comment period on a draft guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” 01/12/2018

FDA Advisory Panel to Review Pacira sNDA for Exparel
Federal Register notice: FDA announces a 2/14-15 Anesthetic and Analgesic Drug Products Advisory Committee meeting to review a Pacira Pharmaceuticals supplemental NDA for Exparel. 01/11/2018

Info Collection Extension Sought for Application Certifications
Federal Register notice: FDA requests OMB clearance for an information collection extension for “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) OMB Control Number 0910-0616.” 01/11/2018

Regulatory Review Period Determined for Entyce
Federal Register notice: FDA determines that the regulatory review period for RaQualia Pharma’s Entyce (capromorelin), indicated for appetite stimulation in dogs, was 1,645 days. 01/11/2018

Risk Communication Panel to Discuss Pregnancy/Lactation Labeling
Federal Register notice: FDA announces a 3/5-6 Risk Communication Advisory Committee meeting to discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products. 01/10/2018

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