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Press releases from FDA
Updated: 15 min 54 sec ago

FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

Fri, 2018-06-22 11:55
FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients

FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

Thu, 2018-06-21 16:10
FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Tue, 2018-06-19 14:03
Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

Tue, 2018-06-19 09:27
FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act

Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products

Fri, 2018-06-15 09:04
Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence

Thu, 2018-06-14 15:49
: FDA approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

Thu, 2018-06-14 08:26
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

Tue, 2018-06-12 09:44
FDA issues draft guidance on collecting patient experiences to inform the development and evaluation of medical products

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Tue, 2018-06-12 09:20
The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Tue, 2018-06-12 08:33
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Federal judge enters consent decree against Delta Pharma

Fri, 2018-06-08 15:39
Federal judge enters consent decree against Delta Pharma

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

Thu, 2018-06-07 12:41
Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

Wed, 2018-06-06 15:27
FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

Wed, 2018-06-06 09:31
FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

Tue, 2018-06-05 13:19
FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers by aligning USDA program with FDA’s Produce Safety Rule requirements.

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

Tue, 2018-06-05 10:27
FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

Tue, 2018-06-05 09:08
FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment

Mon, 2018-06-04 15:53
FDA approves Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer.

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office

Mon, 2018-06-04 07:55
FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs.

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