Istituzioni

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

Food and Drug Administration - Gi, 30/08/2018 - 22:24
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).
Categorie: Istituzioni

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

Food and Drug Administration - Me, 29/08/2018 - 20:43
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Categorie: Istituzioni

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

Food and Drug Administration - Me, 29/08/2018 - 17:16
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 28/08/2018 - 17:19
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
Categorie: Istituzioni

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

Food and Drug Administration - Ma, 28/08/2018 - 16:29
FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales
Categorie: Istituzioni

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

Food and Drug Administration - Gi, 23/08/2018 - 18:03
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.
Categorie: Istituzioni

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

Food and Drug Administration - Me, 22/08/2018 - 23:04
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).
Categorie: Istituzioni

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

Food and Drug Administration - Me, 22/08/2018 - 16:05
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.
Categorie: Istituzioni

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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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
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