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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August 2018
- August 10, 2018 - FDA approves new treatment for a rare genetic disorder, Fabry disease
- August 10, 2018 - FDA approves new vaginal ring for one year of birth control
- August 10, 2018 - FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
- August 10, 2018 - FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy
- August 08, 2018 - FDA approves treatment for two rare types of non-Hodgkin lymphoma
- August 08, 2018 - FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
- August 08, 2018 - FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests
- August 06, 2018 - FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder
- August 03, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
- August 01, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products
July 2018
- July 31, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
- July 30, 2018 - FDA approves first treatment for rare adrenal tumors
- July 30, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”
- July 26, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products
- July 24, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution
- July 24, 2018 - FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer
- July 23, 2018 - FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients
- 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 - 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 25, 2018 - FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
- 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