FDA issued guidance for certain labeling recommendations for breast implants as part of the agency’s effort to improve the information available to patients and health care professionals about the risks of breast implants.

Today FDA approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.

FDA issues an updated summary of the agency’s COVID-19 response efforts.

Today, HHS and FDA took actions to help provide safe, effective, and more affordable drugs to American patients by completing the rulemaking to allow states to import certain prescription drugs from Canada.

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues updated recommendations on dental amalgam and potential risks to certain high-risk individuals that may be associated with mercury-containing fillings used to restore the missing structure and surfaces of a decayed tooth.

Today, the FDA issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.

Coronavirus (COVID-19) Update: Daily Roundup

FDA issues a Drug Safety Communication announcing a class-wide labeling change for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to help improve their safe use.

FDA finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands

FDA launches the Digital Health Center of Excellence within CDRH, furthering FDA’s dedication to the advancement of digital health technology - including mobile health devices, Software as a Medical Device, wearables when used as a medical device, and technologies used to study medical products.

FDA proposal to clarify regulations about the types of evidence relevant to determining how a manufacturer intends for its product to be used by health care providers and patients, an area known as intended use.

FDA’s actions on a new video for consumers and an updated guidance in its ongoing response to the COVID-19 pandemic.

The FDA has proposed a new rule that lays the foundation for end-to-end food traceability across the food industry that we’ll be working toward over the next decade as part of the New Era of Smarter Food Safety initiative.

FDA’s action on a reissued Emergency Use Authorization in its ongoing response to the COVID-19 pandemic.

FDA’s actions on a new abbreviated drug application approval and a warning to consumers and health care professionals in its ongoing response to the COVID-19 pandemic.

Coronavirus (COVID-19) Update: Daily Roundup for September 16, 2020

The FDA published comparative performance data for some authorized COVID-19 molecular diagnostic tests.

FDA issues two warning letters in its ongoing response to the COVID-19 pandemic.

FDA announced that an Illinois-based food manufacturer has agreed to stop production until it undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.