FDA approves new kind of treatment for hairy cell leukemia
FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia
Archive for the ‘Drug Recalls & Safety Notices’ category
Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health
FDA Statement on agency efforts to work with tech industry to spur innovation in digital health
FDA awards five grants to advance the development of pediatric medical devices
FDA has awarded grants to five Pediatric Device Consortia that will provide advice to innovators of children’s medical devices
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use
FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access
FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth access
Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom
Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom
USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry
WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.
FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence
FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states
FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs
Statement from FDA Commissioner Scott Gottlieb, M.D., on an updated approach for including added sugar information on the Nutrition Facts labels of pure maple syrup and honey
Proposed rule revises front of package calorie labeling requirements to provide more flexibility to industry
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities
FDA is publishing its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections in an effort to ensure the quality and safety of globally produced products.
La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos
La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos
FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles
FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs
The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants […]
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings
FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products