Drugs

Latest Federal Register Notices

Joint Panel to Review Alkermes Depression NDA
Federal Register notice: FDA announces an 11/1 joint advisory committee meeting to review an Alkermes NDA for major depressive disorder. 09/21/2018

Draft Guide on Clinicaltrials.com Money Penalties
Federal Register notice: FDA makes available a draft guidance entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.” 09/21/2018

Guide on Product Identifier Requirements
Federal Register notice: FDA makes available a final guidance entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act— Compliance Policy.” 09/20/2018

Guide on Heparin Labeling and Safety Testing
Federal Register notice: FDA makes available a final guidance entitled “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” 09/20/2018

Guide: Grandfathering Product Sans Product Identifier
Federal Register notice: FDA makes available a final guidance entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” 09/20/2018

Q&A Guide on Product Identifiers
Federal Register notice: FDA makes available a draft guidance entitled “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.” 09/20/2018

Docket Number Corrected on Post-approval Changes Guide
Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled “Post-approval Changes to Drug Substances; Draft Guidance for Industry; Availability.” 09/19/2018

Comments Sought on Pediatric Safety Reviews
Federal Register notice: FDA establishes a public docket to collect comments related to the post-marketing, pediatric-focused safety reviews of products posted between 4/2 and 9/14 on FDA’s Web site. 09/18/2018

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