Pharma & Drug Safety

FDA Safety Labeling Change for Fluzone Vaccine

The FDA has notified Sanofi Pasteur Inc. of a required safety labeling change for Fluzone vaccine. Postmarketing studies indicate an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination. This change mandates updating the 'Warnings and Precautions' section of the vaccine's labeling.

FDA Safety Labeling Change for FluMist

The FDA has notified MedImmune, LLC of a required safety labeling change for FluMist, an influenza vaccine. The change is based on postmarketing studies indicating an increased risk of febrile seizures in children aged 6 months through 4 years following vaccination.

FDA Notification: Influenza Vaccine Safety Labeling Change

The FDA has notified ID Biomedical Corporation of Quebec (GlaxoSmithKline Biologicals) of a required safety labeling change for its FLULAVAL influenza vaccine. Postmarketing studies indicate an increased risk of febrile seizures in young children following vaccination, necessitating updates to the product's prescribing information.

FDA Pilot for Medical Device Recall Communication

The FDA's Center for Devices and Radiological Health (CDRH) is launching a pilot program to improve the speed of communication regarding high-risk medical device recalls. This initiative focuses initially on specific device categories and aims to reduce the time between the FDA's awareness of a potential issue and public notification.

FDA Idea Lab for Home Health Medical Devices

The FDA has launched an Idea Lab as part of its Home as a Health Care Hub initiative to foster the development of new home health medical devices. The lab focuses on diabetes management as a test case, aiming to integrate devices for prevention, diagnosis, treatment, rehabilitation, and monitoring into patients' lifestyles.

FDA Approves First Device for Pancreatic Cancer

The FDA has approved the first medical device specifically designed to treat pancreatic cancer. This approval marks a significant advancement in the treatment options available for patients diagnosed with this disease.

FDA CDRH Statements on Medical Device News and Regulatory Updates

The FDA's Center for Devices and Radiological Health (CDRH) provides a collection of statements and updates on medical device news and regulatory matters. This page serves as a repository for announcements, initiatives, and reports from CDRH, offering insights into their ongoing work and priorities.

FDA Lists Expiration Dates for At-Home COVID-19 Tests

The FDA has updated its list of authorized at-home COVID-19 diagnostic tests, including information on extended expiration dates. This guidance helps consumers and healthcare providers identify currently valid tests.

FDA Guidance: Cancer Trial Eligibility Criteria

The FDA has issued new guidance regarding eligibility criteria for cancer clinical trials, specifically addressing washout periods and concomitant medications. This guidance aims to help sponsors and IRBs develop trials that are inclusive while ensuring participant safety. Comments on the guidance can be submitted at any time.

FDA Guidance: Cancer Trial Eligibility Criteria - Laboratory Values

The FDA has issued new guidance on cancer clinical trial eligibility criteria, specifically focusing on laboratory values. The guidance aims to help sponsors and institutional review boards select appropriate laboratory values to avoid unjustified exclusions of diverse patient populations.