Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
FDA approves first treatment for rare adrenal tumors
FDA warns doctors and patients about deceptive claims on laser medical devices used to treat menopausal symptoms for “vaginal rejuvenation”
Process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products
The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.
FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer
FDA continues making progress on bulk drug substances for compounding
The FDA responds to Bayer’s announcement to halt Essure sales in the US
FDA approves new drug for the treatment of adults with acute myeloid leukemia who have a specific genetic mutation and a companion diagnostic to detect specific mutations in the IDH1 gene in patients with AML
FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.
Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA
FDA forms work group on drug importation policy options to address certain patient access challenges
FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
New York-based food processors agree to stop food preparation operations due to food safety violations
FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers
FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure
FDA today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.