Error message

  • The file could not be created.
  • The file could not be created.

News & Events

Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs

Wed, 2019-10-16 11:51
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued progress enhancing patient access to high-quality, low-cost generic drugs

FDA approves new treatment for patients with migraine

Fri, 2019-10-11 13:20
The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.

FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

Thu, 2019-10-10 12:40
Today, FDA allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens. The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test FDA has allowed to be marketed in the U.S. for Ebola Virus Disease (EVD).

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder

Tue, 2019-10-08 12:21
FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder

FDA awards two grants for natural history studies in rare diseases

Tue, 2019-10-08 10:04
FDA awards two grants for natural history studies in rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

Tue, 2019-10-08 09:31
FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

Statement on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses

Fri, 2019-10-04 13:01
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses

FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

Thu, 2019-10-03 13:33
FDA approved Descovy in at-risk adults and adolescents for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.

FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

Tue, 2019-10-01 10:03
FDA is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity vulnerabilities, referred to as “URGENT/11,” that—if exploited by a remote attacker—may introduce risks for medical devices and hospital networks

Statement on measuring the progress being made through implementing the FDA Food Safety Modernization Act

Mon, 2019-09-30 12:41
New performance measures show progress being made in implementing the Food Safety Modernization Act

FDA and DEA warn website operators illegally selling opioids

Mon, 2019-09-30 10:05
FDA and DEA issued joint warning letters to online networks illegally marketing unapproved and misbranded versions of opioids that are potentially dangerous.

Statement on continued efforts to evaluate materials in medical devices to address potential safety questions

Mon, 2019-09-30 08:42
FDA announces next steps the agency is taking as part of its ongoing work to better evaluate the safety of specific materials used in medical devices. This includes holding our first public advisory committee meeting to convene experts and the public on this issue and providing new information on sc

FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels

Fri, 2019-09-27 12:39
FDA approves Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children ages 2 and older in combination with steroid hormones. It is the first approved treatment for children with these rare vasculitis diseases.

FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks

Thu, 2019-09-26 14:05
FDA expands approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children with hepatitis C virus genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve).

Statement on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

Thu, 2019-09-26 08:21
Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

Remarks prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses

Wed, 2019-09-25 09:38
Remarks from Acting FDA Commissioner Ned Sharpless, M.D. as prepared for testimony before a U.S. House Energy and Commerce Subcommittee on FDA Regulation of Electronic Nicotine Delivery Systems and Investigation of Vaping Illnesses

FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity

Tue, 2019-09-24 17:46
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.

FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox

Tue, 2019-09-24 14:15
The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the

Statement on FDA efforts to encourage patient engagement in medical device clinical investigations

Mon, 2019-09-23 09:35
FDA releases draft guidance providing our proposed recommendations for manufacturers to engage patients in multiple aspects of medical device clinical investigation design

Statement on final guidance to help advance development of novel treatments for ALS

Mon, 2019-09-23 09:10
Statement on final guidance to help advance development of novel treatments for ALS

Pages