Archive for the ‘Food Safety News’ category

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

August 23, 2018

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

August 22, 2018

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

August 22, 2018

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

August 17, 2018

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

FDA approves first generic version of EpiPen

August 16, 2018

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

August 16, 2018

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

August 16, 2018

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

August 15, 2018

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

August 10, 2018

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

August 10, 2018

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

August 10, 2018

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

August 10, 2018

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

August 8, 2018

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

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

August 8, 2018

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

August 8, 2018

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

August 6, 2018

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

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

August 6, 2018

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

August 3, 2018

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

August 1, 2018

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

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