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Press releases from FDA
Updated: 2 hours 51 min ago

FDA approves treatment for two rare types of non-Hodgkin lymphoma

Wed, 2018-08-08 10:33
FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

Wed, 2018-08-08 10:18
FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

Mon, 2018-08-06 08:18
FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

Fri, 2018-08-03 08:54
FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval as new drugs.

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

Wed, 2018-08-01 07:59
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

Tue, 2018-07-31 09:43
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

FDA approves first treatment for rare adrenal tumors

Mon, 2018-07-30 14:57
FDA approves first treatment for rare adrenal tumors

Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”

Mon, 2018-07-30 12:41
FDA warns doctors and patients about deceptive claims on laser medical devices used to treat menopausal symptoms for “vaginal rejuvenation”

Statement from FDA Commissioner Scott Gottlieb, M.D., on the process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

Thu, 2018-07-26 08:11
Process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

Tue, 2018-07-24 15:42
The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

Tue, 2018-07-24 13:42
FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

Fri, 2018-07-20 10:54
FDA approves new drug for the treatment of adults with acute myeloid leukemia who have a specific genetic mutation and a companion diagnostic to detect specific mutations in the IDH1 gene in patients with AML

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Fri, 2018-07-20 10:23
FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

Thu, 2018-07-19 14:38
Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan

Wed, 2018-07-18 13:26
FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

Wed, 2018-07-18 09:40
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

New York-based food processors agree to stop food preparation operations due to food safety violations

Tue, 2018-07-17 14:19
New York-based food processors agree to stop food preparation operations due to food safety violations

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