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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November 2018
- November 20, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety
- November 20, 2018 - FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease
- November 19, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk
- November 16, 2018 - FDA approves new drug to treat travelers’ diarrhea
- November 16, 2018 - Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry
- November 16, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
- November 16, 2018 - FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot
- November 16, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials
- November 15, 2018 - Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year
- November 15, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
- November 14, 2018 - FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices
- November 13, 2018 - FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
- November 09, 2018 - FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse
- November 09, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs
- November 09, 2018 - FDA authorizes emergency use of first Ebola fingerstick test with portable reader
- November 08, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program
- November 08, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma
- November 05, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market
- November 02, 2018 - FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
- November 02, 2018 - FDA and DoD formalize collaboration to advance medical products in support of American military personnel
- November 02, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids
- November 02, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
- November 01, 2018 - FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin
- November 01, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks
- November 01, 2018 - Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure
- November 01, 2018 - Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications
October 2018
- October 31, 2018 - FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
- October 31, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use
- October 30, 2018 - FDA takes action to stop the use of lead acetate in hair dyes
- October 30, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation
- October 29, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies
- October 24, 2018 - FDA permits marketing of a diagnostic test to aid in the determination of menopausal status
- October 24, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act
- October 24, 2018 - FDA approves new drug to treat influenza
- October 23, 2018 - Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer
- October 23, 2018 - FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
- October 23, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths
- October 22, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death
- October 19, 2018 - Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements
- October 18, 2018 - Trump Administration Launches “Winning on Reducing Food Waste” Initiative
- October 16, 2018 - FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ 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