FDA Policy/General

Latest Federal Register Notices

Guide on Unapproved New Animal Drug Index
Federal Register notice: FDA has made available a guidance entitled ‘‘The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.’’ The document describes the process for adding a new animal drug to the index. To view the notice, click here. 4/27/2018

Guide on Multi Function Device Products
Federal Register notice: FDA has made available a draft guidance entitled ‘‘Multiple Function Device Products: Policy and Considerations.’’ This draft guidance provides the agency’s regulatory approach for products with multiple functions, including at least one device function, in accordance with the 21st Century Cures Act. To view the notice, click here. 4/27/2018

Guide on Clinical Trial Imaging Standards
Federal Register notice: FDA has made available a guidance entitled ‘‘Clinical Trial Imaging Endpoint Process Standards.’’ The document is intended to assist sponsors in optimizing the quality of imaging data obtained in clinical trials that will support product approvals. It focuses on imaging acquisition, display, archiving, and interpretation process standards that FDA regards as important when imaging is used to assess a trial’s primary endpoint or a component of that endpoint. To view the notice, click here. 4/27/2018

FDA Vaccines Panel to Discuss Strep Vaccines Effectiveness
Federal Register notice: FDA has announced a 5/17 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss approaches for demonstrating effectiveness of group B streptococcus vaccines intended for use in pregnant women to protect the newborn infant. Also, they will be presented with an overview of the research program in the CBER’s Laboratory of Respiratory Viral Diseases. To view the notice, click here. 4/25/2018

Joint FDA Panel to Meet About Achondroplasia Treatments
Federal Register notice: FDA has announced a 5/11 joint Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss drug development for treating children with achondroplasia. Topics to be discussed include the evidence required to establish dose-response, study design, study duration, intended population, and endpoints. To view the notice, click here. 4/25/2018

Guide on Nonclinical Development for Hematologic Disorders
Federal Register notice: FDA has made available a draft guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The document is intended to provide information to assist sponsors in designing appropriate nonclinical studies for developing such products. It also discusses a streamlined approach to drug development to allow patients with these conditions access to new and potentially effective therapies. To view the notice, click here. 4/24/2018

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

Read more

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