Istituzioni

FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market

FDA efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility

The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

FDA provides updates on post-marketing study that agency ordered three manufacturers of duodenoscopes to conduct to prevent bacterial contamination of devices.

FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information.

FDA issues a final rule designed to help ensure that hand sanitizers available over-the-counter are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review.

Declaración de la FDA sobre las acciones de aplicación de las normas sobre células madre y las actividades de la dependencia para facilitar el desarrollo de productos legítimos

FDA is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.

The agencies announced the release of a federal interagency strategy to address food waste.

FDA approves a new treatment for osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).

Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects

FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received antiretroviral treatment for HIV.

FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin

FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications

The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities.

FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers

FDA shares its 2019 compounding priorities as the agency works to improve the quality of compounded drugs

FDA takes new steps to increase access to adverse event report data for medical products used in animals

FDA statement on stem cell enforcement actions and agency activities to facilitate legitimate product development