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Press releases from FDA
Updated: 1 hour 17 min ago

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

Mon, 2019-03-04 11:55
Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan.

FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall

Fri, 2019-03-01 08:45
FDA provides update on ongoing investigation into ARB drugs; new losartan recall announced

FDA warns CanaRx for selling unapproved, misbranded and unsafe imported drugs to unsuspecting Americans

Thu, 2019-02-28 14:46
FDA issued a warning letter to CanaRx for illegally distributing drugs into the U.S. that have not been approved by the FDA for safety and effectiveness.

Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

Wed, 2019-02-27 15:25
FDA addresses the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

Tue, 2019-02-26 11:00
FDA outlines 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse.

FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

Tue, 2019-02-26 09:17
FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on a new strategy to advance FDA’s food safety mission and modernize oversight of imported food

Mon, 2019-02-25 12:13
American consumers expect a diverse, robust and fresh food supply that’s affordable and safe all year round. Since not all food products can be produced solely by domestic facilities, to help meet these demands, the U.S. imports about 15 percent of its overall food supply from more than 200 countries or territories representing about 125,000 international food facilities and farms. Over the past 15 years alone, we’ve seen a trend of rising imported foods. Other countries now supply about 32 percent of the fresh vegetables, 55 percent of the fresh fruit and 94 percent of the seafood that Americans enjoy.

FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

Mon, 2019-02-25 09:18
FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Fri, 2019-02-22 09:30
Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to spur development of innovative devices, including new advancements in novel brain implants, that can help patients with paralysis or amputation gain mobility

Statement from FDA Commissioner Scott Gottlieb, M.D., on additional steps by the agency to support the development of safe and effective novel nicotine replacement therapies to help smokers quit cigarettes

Thu, 2019-02-21 09:07
FDA releases the second of two draft guidances aimed at supporting the development of novel nicotine replacement therapies.

FDA advances new proposed regulation to make sure that sunscreens are safe and effective

Thu, 2019-02-21 08:01
FDA issues a proposed rule that would update regulatory requirements for most sunscreen products in the United States

Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven...

Tue, 2019-02-19 09:54
FDA statement cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

Fri, 2019-02-15 09:00
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

Thu, 2019-02-14 14:29
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

Thu, 2019-02-14 11:43
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 <em>E. coli</em> O157:H7 in California-linked romaine lettuce

Wed, 2019-02-13 10:20
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

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

Tue, 2019-02-12 08:51
FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.

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