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New performance measures show progress being made in implementing the Food Safety Modernization Act

FDA and DEA issued joint warning letters to online networks illegally marketing unapproved and misbranded versions of opioids that are potentially dangerous.

FDA announces next steps the agency is taking as part of its ongoing work to better evaluate the safety of specific materials used in medical devices. This includes holding our first public advisory committee meeting to convene experts and the public on this issue and providing new information on sc

FDA approves Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children ages 2 and older in combination with steroid hormones. It is the first approved treatment for children with these rare vasculitis diseases.

FDA expands approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children with hepatitis C virus genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).

Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

Remarks from Acting FDA Commissioner Ned Sharpless, M.D. as prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses

The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the

FDA releases draft guidance providing our proposed recommendations for manufacturers to engage patients in multiple aspects of medical device clinical investigation design

Statement on final guidance to help advance development of novel treatments for ALS

Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths

FDA approves Rybelsus (semaglutide) oral tablets to improve blood sugar in adults with type 2 diabetes, with diet and exercise. It is first GLP-1 receptor protein treatment approved in U.S.

FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products

FDA recommends duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety.

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

FDA is issuing draft guidances outlining recommended premarket performance criteria and testing methodologies for four specific types of devices under the Safety and Performance Based Pathway for medical devices.

: FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy

FDA and CDC are providing updates about federal and state efforts to investigate respiratory illnesses reported after the use of e-cigarette products.

The FDA is issuing an update regarding the ongoing efforts to resolve safety issues with ARB medications.

: FDA intends to finalize compliance policy that would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes, clearing the market these products.