Istituzioni

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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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”

Food and Drug Administration - 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

Food and Drug Administration - 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

Food and Drug Administration - 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

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

Food and Drug Administration - Ma, 24/07/2018 - 20:42
FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer
Categorie: Istituzioni

FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation

Food and Drug Administration - Ve, 20/07/2018 - 17:54
FDA approves new drug for the treatment of adults with acute myeloid leukemia who have a specific genetic mutation and a companion diagnostic to detect specific mutations in the IDH1 gene in patients with AML
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Food and Drug Administration - Ve, 20/07/2018 - 17:23
FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.
Categorie: Istituzioni

Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA

Food and Drug Administration - Gi, 19/07/2018 - 21:38
Statement from FDA warning about significant health risks of contaminated illegal synthetic cannabinoid products that are being encountered by FDA
Categorie: Istituzioni

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan

Food and Drug Administration - Me, 18/07/2018 - 20:26
FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.
Categorie: Istituzioni

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

Food and Drug Administration - Me, 18/07/2018 - 16:40
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
Categorie: Istituzioni

New York-based food processors agree to stop food preparation operations due to food safety violations

Food and Drug Administration - Ma, 17/07/2018 - 21:19
New York-based food processors agree to stop food preparation operations due to food safety violations
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

Food and Drug Administration - Ma, 17/07/2018 - 15:16
FDA describes innovative approaches to increase access to a broader selection of nonprescription drug products for consumers
Categorie: Istituzioni
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