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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September 2018
- September 18, 2018 - FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids
- September 14, 2018 - FDA approves device for treatment of acute coronary artery perforations
- September 14, 2018 - 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
- September 13, 2018 - 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
- September 13, 2018 - FDA approves new kind of treatment for hairy cell leukemia
- September 12, 2018 - FDA awards five grants to advance the development of pediatric medical devices
- September 12, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health
- September 12, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use
- September 12, 2018 - 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
- September 11, 2018 - 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
- September 10, 2018 - USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry
- September 07, 2018 - FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence
- September 07, 2018 - 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
- September 06, 2018 - 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
- September 05, 2018 - 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
August 2018
- August 31, 2018 - FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles
- August 31, 2018 - FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
- August 30, 2018 - District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs
- August 30, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings
- August 29, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
- August 29, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis
- August 28, 2018 - FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
- August 28, 2018 - FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales
- August 23, 2018 - Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings
- August 22, 2018 - FDA approves first drug for neurotrophic keratitis, a rare eye disease
- August 22, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics
- August 17, 2018 - FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
- August 16, 2018 - FDA approves first generic version of EpiPen
- August 16, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
- August 16, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on significant public health value and cost savings resulting from the agency’s youth smoking prevention campaign
- August 15, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals
- 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