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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April 2019
- April 23, 2019 - Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, on new steps to help reduce risks associated with surgical staplers for internal use and implantable staples
- April 23, 2019 - Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls
- April 22, 2019 - Statement from Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research, on FDA’s continued confidence in the safety and effectiveness of the measles, mumps, and rubella (MMR) vaccine
- April 19, 2019 - FDA permits marketing of first medical device for treatment of ADHD
- April 19, 2019 - FDA approves first generic naloxone nasal spray to treat opioid overdose
- April 16, 2019 - FDA Statement from Deputy Commissioner for Food Policy and Response Frank Yiannas on new steps to protect consumers from unlawful ingredients in dietary supplements
- April 16, 2019 - FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
- April 12, 2019 - Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility
- April 12, 2019 - FDA approves first targeted therapy for metastatic bladder cancer
- April 12, 2019 - Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk
- April 11, 2019 - FDA orders important safety labeling changes for Addyi
- April 11, 2019 - FDA issues final rule on safety and effectiveness of consumer hand sanitizers
- April 10, 2019 - FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion
- April 09, 2019 - USDA, EPA, and FDA Unveil Strategy to Reduce Food Waste
- April 09, 2019 - FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture
- April 09, 2019 - Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids
- April 08, 2019 - FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment
- April 08, 2019 - FDA warns about risks of using home use test strips that are pre-owned or not authorized for sale in U.S., including those for glucose, warfarin
- April 04, 2019 - FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
- April 04, 2019 - FDA expands approved use of metastatic breast cancer treatment to include male patients
- April 04, 2019 - FDA and CBP bolster collaboration to protect public health and safety
- April 04, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue
- April 03, 2019 - Declaración del comisionado de la FDA sobre los esfuerzos continuos para impedir que las clínicas de células madre comercialicen productos no aprobados, y que reitera al mismo tiempo el compromiso de la dependencia de ayudar a avanzar en el desarrollo de productos legítimos de células madre bajo las regulaciones existentes
- April 03, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs
- April 03, 2019 - FDA takes new steps to increase access to adverse event report data for medical products used in animals
- April 03, 2019 - Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk, while progressing the agency’s commitment to help advance legitimate stem cell product development under existing agency regulations
- April 03, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
- April 02, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D. on steps toward a new, tailored review framework for artificial intelligence-based medical devices
- April 02, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products
- April 02, 2019 - USDA, EPA, and FDA Recognize April as Winning on Reducing Food Waste Month
- April 02, 2019 - FDA takes new enforcement actions as part of the agency’s ongoing effort to combat the illegal online sales of opioids
- April 02, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access
- April 01, 2019 - FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
- April 01, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes
March 2019
- March 29, 2019 - FDA approves new oral treatment for multiple sclerosis
- March 29, 2019 - Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward
- March 28, 2019 - FDA approves treatment for patients with a type of inflammatory arthritis
- March 28, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule
- March 28, 2019 - Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Subcommittee on Appropriations on FDA’s Fiscal Year 2020 budget
- March 27, 2019 - FDA approves new oral testosterone capsule for treatment of men with certain forms of hypogonadism
- March 27, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen agency’s safety requirements aimed at mitigating risks associated with transmucosal immediate-release fentanyl products
- March 27, 2019 - FDA advances landmark policy changes to modernize mammography services and improve their quality
- March 26, 2019 - FDA approves new oral drug to treat multiple sclerosis
- March 26, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility
- March 26, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., on efforts to promote and foster blood pathogen reduction technologies
- March 21, 2019 - FDA approves new device for treating moderate to severe chronic heart failure in patients
- March 19, 2019 - FDA approves first treatment for post-partum depression
- March 19, 2019 - FDA issues warning letters to two breast implant manufacturers for failure to comply with post-approval study requirements
- March 19, 2019 - Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond
- March 19, 2019 - FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions