Drugs

Latest Federal Register Notices

Members Sought for Mammography Quality Panel
Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. 09/07/2018

Guide on Dietary Supplement Microbial Labeling
Federal Register notice: FDA makes available a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” 09/07/2018

Nonallergic Rhinitis Drug Development Guide
Federal Register notice: FDA makes available a guidance entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” 09/06/2018

Guide on Allergic Rhinitis Drug Development
Federal Register notice: FDA makes available a guidance entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” 09/06/2018

Comments Extended for Gene Therapy Guidances
Federal Register notice: FDA extends the comment period on six draft guidance documents about developing human gene therapy products. 09/06/2018

Guide on Uncertainty in Device Benefit-Risk Determinations
Federal Register notice: FDA makes available a draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” 09/06/2018

Info Collection Extension for Drug Supply Chain Guide
Federal Register notice: FDA seeks comments on an information collection extension entitled “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” 09/05/2018

CDRH Seeks Members for Radiation Safety Panel
Federal Register notice: FDA seeks nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. 09/05/2018

Final Guide on Pharmacokinetic Analyses
Federal Register notice: FDA releases a final guidance entitled “Physiologically Based Pharmacokinetic Analyses — Format and Content.” 09/04/2018

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