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Press releases from FDA
Updated: 57 min 31 sec ago

Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s commitment to studying breast implant safety

Fri, 2018-09-14 10:49
FDA Statement on agency’s commitment to studying breast implant safety Short Title: FDA Statement on agency’s commitment to studying breast implant safety

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

Thu, 2018-09-13 15:12
FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

FDA approves new kind of treatment for hairy cell leukemia

Thu, 2018-09-13 12:54
FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia

FDA awards five grants to advance the development of pediatric medical devices

Wed, 2018-09-12 11:27
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

Wed, 2018-09-12 08:32
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

Wed, 2018-09-12 08:22
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

Tue, 2018-09-11 09:58
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

Mon, 2018-09-10 13:07
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

Fri, 2018-09-07 15:18
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

Fri, 2018-09-07 09:24
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

Thu, 2018-09-06 09:04
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

Wed, 2018-09-05 10:22
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

Fri, 2018-08-31 16:26
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

Fri, 2018-08-31 12:07
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

Fri, 2018-08-31 08:33
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

Thu, 2018-08-30 15:24
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 to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law

Wed, 2018-08-29 13:43
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

Wed, 2018-08-29 10:16
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.

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