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 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
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