Food and Drug Administration

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Press releases from FDA
Aggiornato: 5 ore 41 min fa

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

Ve, 17/08/2018 - 15:46
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
Categorie: Istituzioni

FDA approves first generic version of EpiPen

Gi, 16/08/2018 - 18:55
FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans

Gi, 16/08/2018 - 18:34
FDA announces workshop on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on significant public health value and cost savings resulting from the agency’s youth smoking prevention campaign

Gi, 16/08/2018 - 16:06
A cost-effectiveness analysis of the FDA’s “The Real Cost” youth smoking prevention campaign shows it has resulted in savings of more than $31 billion for youth, their families and society at large.
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals

Me, 15/08/2018 - 18:14
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide in support of responsible opioid prescribing for safe, effective pain management in animals
Categorie: Istituzioni

FDA approves new treatment for a rare genetic disorder, Fabry disease

Ve, 10/08/2018 - 22:37
FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.
Categorie: Istituzioni

FDA approves new vaginal ring for one year of birth control

Ve, 10/08/2018 - 19:54
FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.
Categorie: Istituzioni

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

Ve, 10/08/2018 - 18:51
FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
Categorie: Istituzioni

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

Ve, 10/08/2018 - 18:02
The app uses basal body temperature readings to predict when a woman is most fertile to help her avoid conceiving on those days if using as a form of contraception
Categorie: Istituzioni

FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

Me, 08/08/2018 - 19:33
FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests
Categorie: Istituzioni

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

Me, 08/08/2018 - 17:33
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
Categorie: Istituzioni

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

Me, 08/08/2018 - 17:18
FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition
Categorie: Istituzioni

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

Lu, 06/08/2018 - 15:18
FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.
Categorie: Istituzioni

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

Ve, 03/08/2018 - 15:54
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.
Categorie: Istituzioni

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

Me, 01/08/2018 - 14:59
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products
Categorie: Istituzioni

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

Ma, 31/07/2018 - 16:43
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
Categorie: Istituzioni

FDA approves first treatment for rare adrenal tumors

Lu, 30/07/2018 - 21:57
FDA approves first treatment for rare adrenal tumors
Categorie: Istituzioni

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”

Lu, 30/07/2018 - 19:41
FDA warns doctors and patients about deceptive claims on laser medical devices used to treat menopausal symptoms for “vaginal rejuvenation”
Categorie: Istituzioni

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

Gi, 26/07/2018 - 15:11
Process FDA is undertaking for reviewing and modernizing the agency’s standards of identity for dairy products
Categorie: Istituzioni

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

Ma, 24/07/2018 - 22:42
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.
Categorie: Istituzioni