Pharma & Life Sciences

FDA Guidance on Defining Drug Use Durations for Medically Important Antimicrobials

The FDA has finalized guidance (GFI #273) recommending how animal drug sponsors can voluntarily establish defined durations of use for medically important antimicrobial drugs administered in feed to food-producing animals. Over 100 drugs are affected, and sponsors are expected to submit revised labeling within approximately three years.

FDA Issues Emergency Use Authorization for Ivomec to Prevent Screwworm in Cattle

The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution to prevent New World screwworm infestations in cattle. This authorization allows for over-the-counter use under specific conditions and is effective until the declared emergency is terminated.

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 Notification: Safety Labeling Change for Influenza Vaccine

The FDA has notified GlaxoSmithKline Biologicals of a required safety labeling change for its FLUARIX influenza vaccine. Postmarketing studies indicate 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 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 Warns of Serious Risks from Unapproved Cell/Tissue Products

The FDA is warning consumers and healthcare professionals about the serious risks associated with unapproved human cell and tissue products, including patient deaths. The agency is investigating products like Laennec and reminds the public to report adverse events.

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 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 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.