FDA Policy/General

Comments Sought on FDA Posting REMS Assessments

Federal Register notice: FDA has announced the establishment of a docket to solicit public comment on a proposal to publish a summary of FDA’s review of Risk Evaluation and Mitigation Strategy (REMS) assessments. The purpose of the docket is to increase agency transparency and promote exchange of information regarding the assessment of REMS programs. FDA has received feedback from healthcare providers, healthcare systems, industry members, researchers, professional organizations, and other federal agencies, indicating that it would be beneficial to make both the applicant’s REMS Assessment Report and FDA’s review of this report available in the public domain for a number of purposes. For example, industry may consider the effectiveness of a particular strategy as they develop a new REMS; healthcare providers may have an interest in the assessment of a REMS that they participate in; and academics can use the information for research purposes. In response to this feedback, FDA is proposing to post to its “Approved REMS” Web page (https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm) a summary of FDA’s review of an applicant’s REMS Assessment Report, which would include a high-level summary of the data included in the applicant’s REMS Assessment Report and will include a summary of the FDA review of whether the REMS is meeting its risk mitigation goals. To view the notice, click here.

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