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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June 2018
- June 22, 2018 - FDA permits marketing of first catheter-based systems used to create vascular access for hemodialysis patients
- June 21, 2018 - FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
- June 21, 2018 - FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes
- June 19, 2018 - Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products
- June 19, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply
- June 15, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Anna Abram on emerging food innovation, “cultured” food products
- June 14, 2018 - FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence
- June 14, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food
- June 12, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making
- June 12, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
- June 12, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care
- June 08, 2018 - Federal judge enters consent decree against Delta Pharma
- June 07, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products
- June 06, 2018 - FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens
- June 06, 2018 - FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act
- June 05, 2018 - FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers
- June 05, 2018 - FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales
- June 05, 2018 - FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products
- June 04, 2018 - FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment
- June 04, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed modernization of FDA’s drug review office
May 2018
- May 31, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s work to mitigate shortages of intravenous drugs, shorten supply disruptions and better predict vulnerabilities
- May 31, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access
- May 30, 2018 - FDA approves first artificial iris
- May 30, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo
- May 30, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act
- May 30, 2018 - FDA approves new treatment for moderately to severely active ulcerative colitis
- May 30, 2018 - As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
- May 24, 2018 - FDA approves a new treatment for PKU, a rare and serious genetic disease
- May 24, 2018 - FDA permits marketing of artificial intelligence algorithm for aiding providers in detecting wrist fractures
- May 23, 2018 - FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit
- May 22, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens
- May 22, 2018 - FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses
- May 21, 2018 - FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure
- May 17, 2018 - FDA approves novel preventive treatment for migraine
- May 17, 2018 - FDA requires additional e-cigarette makers to provide critical information so the agency can better examine youth use and product appeal, amid continued concerns around youth access to products
- May 17, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
- May 16, 2018 - FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
- May 15, 2018 - FDA approves first epoetin alfa biosimilar for the treatment of anemia
- May 11, 2018 - FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
- May 11, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
- May 10, 2018 - FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
- May 09, 2018 - FDA seeks permanent injunctions against two stem cell clinics
- May 07, 2018 - FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding
- May 07, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling
- May 04, 2018 - FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer
- May 01, 2018 - FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies
April 2018
- April 24, 2018 - Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA’s Fiscal Year 2019 budget
- April 24, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of, and access to, JUUL and other e-cigarettes
- April 20, 2018 - FDA authorizes new use of test, first to identify the emerging pathogen Candida auris
- April 20, 2018 - Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder