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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October 2018
- October 16, 2018 - FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agency’s broader effort to protect patient safety
- October 15, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies
- October 12, 2018 - FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy
- October 11, 2018 - FDA approves new DNA-based test to determine blood compatibility
- October 09, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
- October 05, 2018 - La FDA aprueba el uso ampliado de Gardasil 9 para incluir a personas de 27 a 45 años de edad
- October 05, 2018 - FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
- October 05, 2018 - FDA allows marketing of first self-fitting hearing aid controlled by the user
- October 02, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
- October 01, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
September 2018
- September 28, 2018 - FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation
- September 28, 2018 - FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma
- September 28, 2018 - FDA approves first treatment for advanced form of the second most common skin cancer
- September 27, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes
- September 27, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations
- September 26, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety
- September 25, 2018 - Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding
- September 24, 2018 - FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
- September 18, 2018 - FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications
- September 18, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora
- September 18, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids
- 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