Press Announcements
Note: Press announcements from 2004 to 2015 are available through the FDA.gov Archive. Some links in press announcements may no longer be active. For more information, contact FDA’s Office of Media Affairs at 301-796-4540.
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July 2018
- July 20, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency’s continued commitment to postmarket review of Essure and keeping women informed
- July 20, 2018 - FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation
- July 20, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
- July 19, 2018 - Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA
- July 19, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities
- July 18, 2018 - Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
- July 18, 2018 - FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
- July 17, 2018 - New York-based food processors agree to stop food preparation operations due to food safety violations
- July 17, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs
- July 13, 2018 - FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity
- July 13, 2018 - FDA approves the first drug with an indication for treatment of smallpox
- July 13, 2018 - FDA warns of imposters sending consumers fake warning letters
- July 12, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages
- July 12, 2018 - FDA expands its support for states to advance implementation of produce safety activities
- July 11, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies
- July 10, 2018 - Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
- July 10, 2018 - FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions
- July 10, 2018 - FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product
- July 09, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on balancing access to appropriate treatment for patients with chronic and end-of-life pain with need to take steps to stem misuse and abuse of opioids
- July 02, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., on the ongoing risk of salmonella in kratom products
June 2018
- June 29, 2018 - FDA approves novel device for treating breathing difficulty from severe emphysema
- June 28, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online
- June 28, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug
- June 28, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on developments in the romaine outbreak investigation, recent outbreaks and the use of modern tools to advance food safety
- June 26, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to advance health through improvements in nutrition under the agency’s Nutrition Innovation Strategy
- June 25, 2018 - FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
- June 25, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
- June 22, 2018 - FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
- June 21, 2018 - FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
- June 21, 2018 - FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes
- June 19, 2018 - 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
- June 19, 2018 - 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
- June 15, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products
- June 14, 2018 - FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence
- June 14, 2018 - 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
- June 12, 2018 - 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
- June 12, 2018 - 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
- June 12, 2018 - 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
- June 08, 2018 - Federal judge enters consent decree against Delta Pharma
- June 07, 2018 - 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
- June 06, 2018 - FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
- June 06, 2018 - 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
- June 05, 2018 - FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers
- June 05, 2018 - FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
- June 05, 2018 - FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products
- June 04, 2018 - FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
- June 04, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office
May 2018
- May 31, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
- May 31, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access
- May 30, 2018 - FDA approves first artificial iris