Drugs

Latest Federal Register Notices

CDRH Seeks to Fill Vacancies on Device Panels
Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee panels. 08/30/2019

Docket No. on Pediatric Rare Disease Corrected
Federal Register notice: FDA corrects the docket number in a 12/2017 notice entitled “Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model.” 08/30/2019

9 Bulk Drugs Proposed for Compounding Exclusion
Federal Register notice: FDA seeks comments on nine bulk drug substances that it is proposing not to allow outsourcing facilities to use in drug compounding. 08/30/2019

Regulatory Review Period for Puma’s Nerlynx
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Puma Bio’s Nerlynx (neratinib). 08/30/2019

Submissions Extended for Quality Metrics Feedback
Federal Register notice: FDA extends the submission period related to a 6/29 notice on its drug Quality metrics feedback program. 08/29/2019

Guide on Cancer Trial Placebo Use & Blinding
Federal Register notice: FDA releases a final guidance on using placebos and allowing blinding in cancer clinical trials. 08/29/2019

Comments Reopened on Dronabinol Scheduling
Federal Register notice: FDA reopens the comment period for a 3/1 notice on international drug scheduling for Dronabinol.08/28/2019

Guide on Drugs for Treating Male Breast Cancer
Federal Register notice: FDA makes available a draft guidance entitled “Male Breast Cancer: Developing Drugs for Treatment.” 08/27/2019

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