Istituzioni

Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids

Food and Drug Administration - Sa, 15/06/2019 - 17:31
FDA is soliciting feedback on the potential use of new authorities under the SUPPORT Act to require certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging.
Categorie: Istituzioni

FDA approves first PI3K inhibitor for breast cancer

Food and Drug Administration - Sa, 15/06/2019 - 17:31
FDA approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant.
Categorie: Istituzioni

FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality

Food and Drug Administration - Ve, 14/06/2019 - 17:00
FDA approves innovative gene therapy to treat pediatric patients with spinal muscular atrophy, a rare disease and leading genetic cause of infant mortality
Categorie: Istituzioni

FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections

Food and Drug Administration - Ma, 11/06/2019 - 15:36
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
Categorie: Istituzioni

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

Food and Drug Administration - Ma, 11/06/2019 - 15:36
FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
Categorie: Istituzioni

FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results

Food and Drug Administration - Lu, 10/06/2019 - 14:45
FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results
Categorie: Istituzioni

FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea

Food and Drug Administration - Ve, 07/06/2019 - 13:26
FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
Categorie: Istituzioni

Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities

Food and Drug Administration - Ve, 07/06/2019 - 13:26
U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction today between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Illinois.
Categorie: Istituzioni

Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions

Food and Drug Administration - Ve, 07/06/2019 - 13:26
A federal court ordered a Texas-based company to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., and Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., on FDA’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in

Food and Drug Administration - Me, 05/06/2019 - 12:18
FDA issues statement on agency’s ongoing scientific investigation of potential safety issue related to seizures reported following e-cigarette use, particularly in youth and young adults
Categorie: Istituzioni

FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue

Food and Drug Administration - Me, 05/06/2019 - 12:18
FDA announces list of nitrosamine-free ARB medications confirmed by the agency to help patients and healthcare providers
Categorie: Istituzioni

FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards

Food and Drug Administration - Ma, 04/06/2019 - 11:39
The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations.
Categorie: Istituzioni

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

Food and Drug Administration - Ma, 04/06/2019 - 11:39
FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.
Categorie: Istituzioni

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on policy advancements to help bring interchangeable biosimilars to market

Food and Drug Administration - Lu, 03/06/2019 - 10:43
FDA announces final guidance on the pathway for “interchangeable” biologics, which may be substituted without the involvement of the prescriber.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on the agency’s 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse

Food and Drug Administration - Lu, 03/06/2019 - 10:43
FDA outlines 2019 policy and regulatory agenda for continued action to forcefully address the tragic epidemic of opioid abuse.
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic

Food and Drug Administration - Lu, 03/06/2019 - 10:43
FDA issues first warning letter under Drug Supply Chain Security Act to McKesson Corp. for violations highlighted by a concerning tampering incident.
Categorie: Istituzioni

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

Food and Drug Administration - Gi, 30/05/2019 - 09:12
FDA informs companies that the agency is not approving their PMA applications and that they will have to remove their products from the market
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility

Food and Drug Administration - Gi, 30/05/2019 - 09:12
The FDA is aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility.
Categorie: Istituzioni

Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in p

Food and Drug Administration - Ve, 24/05/2019 - 06:31
The FDA is issuing two draft guidances, which, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information in drugs used during pregnancy or lactation.
Categorie: Istituzioni
Condividi contenuti