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

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

Food and Drug Administration - Ve, 13/07/2018 - 23:35
FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure
Categorie: Istituzioni

FDA approves the first drug with an indication for treatment of smallpox

Food and Drug Administration - Ve, 13/07/2018 - 21:09
FDA today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox.
Categorie: Istituzioni

FDA warns of imposters sending consumers fake warning letters

Food and Drug Administration - Ve, 13/07/2018 - 16:25
FDA is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone.
Categorie: Istituzioni

Statement by FDA Commissioner Scott Gottlieb, M.D., on formation of a new drug shortages task force and FDA’s efforts to advance long-term solutions to prevent shortages

Food and Drug Administration - Gi, 12/07/2018 - 19:12
FDA Commissioner Scott Gottlieb, M.D., on new drug shortages task force and work towards long-term solutions to prevent shortages
Categorie: Istituzioni

FDA expands its support for states to advance implementation of produce safety activities

Food and Drug Administration - Gi, 12/07/2018 - 16:46
FDA expands its support for states to advance implementation of produce safety activities
Categorie: Istituzioni

Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies

Food and Drug Administration - Me, 11/07/2018 - 16:23
Statement from FDA Commissioner Scott Gottlieb, M.D. on agency’s efforts to advance development of gene therapies, including three disease specific draft guidances
Categorie: Istituzioni

Federal judge enters consent decree against Minnesota dairy farm for drug residue violations

Food and Drug Administration - Ma, 10/07/2018 - 21:40
Federal judge enters consent decree against Minnesota dairy farm for drug residue violations
Categorie: Istituzioni

FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions

Food and Drug Administration - Ma, 10/07/2018 - 21:28
FDA is requiring safety labeling changes for fluoroquinolones to strengthen the warnings about the risks of mental health side effects and serious blood sugar disturbances.
Categorie: Istituzioni

FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product

Food and Drug Administration - Ma, 10/07/2018 - 15:52
FDA granted an EUA to DOD to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP).
Categorie: Istituzioni
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