FDA Policy/General

90% of Public Comments at Panel Meetings Supported Approval: Study

More than 90% of public comments submitted during five FDA drug advisory committee reviews favored approval of the products under consideration, according to a new study examining public participation in the agency's regulatory decision-making process.

The study, published 11/7 in Therapeutic Innovation & Regulatory Science, analyzed 600 public comments associated with five FDA advisory committee meetings held between 2020 and 2024. The meetings concerned treatments for amyotrophic lateral sclerosis (ALS), type 1 diabetes, post-traumatic stress disorder (PTSD), Duchenne muscular dystrophy and pediatric neuroblastoma.

Researchers found that 90.2% of comments favored approval, while just 1.3% opposed it. Caregivers and immediate family members accounted for 31.5% of participants, followed by patients at 17.2%.

The findings highlight the prominence of patients and caregivers in FDA advisory committee proceedings, particularly for serious diseases with limited treatment options.

Boehringer Seeking Survodutide Approval After Reporting Favorable Data

Boehringer Ingelheim says it will seek global approvals for survodutide, which it describes as the first glucagon/GLP-1 dual agonist to demonstrate a favorable cardiovascular safety profile in a Phase 3 trial alongside significant cardiometabolic benefits. The company says its SYNCHRONIZE-CVOT trial met its primary endpoint using both

FDA Seeks Input on Autonomous and Remote-Controlled Medical Robots

FDA is seeking public input on how to evaluate the benefits and risks of medical robots capable of performing tasks autonomously or being operated remotely, as advances in artificial intelligence and connectivity expand their potential clinical applications. In a just-posted discussion paper, CDRH identifies regulatory questions involving autonomous decision-

FDA Orders Eye Safety Warnings for All GLP-1 Drugs

FDA is requiring manufacturers of all glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs to add warnings about a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that can cause sudden, permanent vision loss. NAION typically causes acute, painless vision loss

FDA Posts 18 Form 483 Inspection Records

FDA has posted 20 Form 483 inspection records (see below), including reports involving Novo Nordisk, AnaptysBio, Protagonist Therapeutics, Ascendis Pharma and Charles River Laboratories, as the agency continues expanding public access to inspection findings through its electronic reading room. Their availability is part of the agency’s expanded transparency initiative

Read more

Boehringer Seeking Survodutide Approval After Reporting Favorable Data

FDA Seeks Input on Autonomous and Remote-Controlled Medical Robots

FDA Orders Eye Safety Warnings for All GLP-1 Drugs

FDA Posts 18 Form 483 Inspection Records