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Press releases from FDA
Updated: 47 min 23 sec ago

FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

Fri, 2018-08-31 08:33
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

Thu, 2018-08-30 15:24
The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law

Wed, 2018-08-29 13:43
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

Wed, 2018-08-29 10:16
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

Tue, 2018-08-28 10:19
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

Tue, 2018-08-28 09:29
FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

Thu, 2018-08-23 11:03
FDA announced that all 17 manufacturers, distributors, and retailers that were warned in May have stopped selling the e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products.

FDA approves first drug for neurotrophic keratitis, a rare eye disease

Wed, 2018-08-22 16:04
FDA approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

Wed, 2018-08-22 09:05
FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine to advance the development of evidence-based, indication-specific guidelines to help guide appropriate opioid prescribing.

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

Fri, 2018-08-17 08:46
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA approves first generic version of EpiPen

Thu, 2018-08-16 11:55
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.

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

Thu, 2018-08-16 11:34
FDA announces workshop on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans.

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

Thu, 2018-08-16 09:06
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.

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

Wed, 2018-08-15 11:14
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

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

Fri, 2018-08-10 15:37
FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

FDA approves new vaginal ring for one year of birth control

Fri, 2018-08-10 12:54
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.

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

Fri, 2018-08-10 11:51
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.

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

Fri, 2018-08-10 11:02
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

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

Wed, 2018-08-08 12:33
FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

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