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FDA releases the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies.

FDA issues a proposed rule that would update regulatory requirements for most sunscreen products in the United States

FDA statement cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions

FDA announces new draft guidance titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway.

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Frank Yiannas on findings from the agency’s investigation of the November 2018 outbreak of E. coli O157:H7 in California-linked romaine lettuce

FDA announces programs to promote adoption of innovations in drug manufacturing

FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use.

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease

FDA announces new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight

FDA announces pilot program to improve ability to trace prescription drugs at all points in the drug distribution chain.

FDA has initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the agency’s process for issuing public warnings and notifications of recalls

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants

Federal court enters consent decree against Ranier’s Rx Laboratory and owner for manufacturing purportedly sterile drug products in insanitary conditions

FDA approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.

Medical product distributor issued voluntary recall of certain Roche Diagnostics test strips used with CoaguChek test meter devices.

FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines