USFDA

EMA and USFDA Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications

  • Posted on: 25 November 2018
  • By: Shalini.Sharma

EMA and the US Food and Drug Administration (FDA) are organising a workshop on 26 November 2018 to discuss how regulators can better guide and support medicine developers in generating quality and manufacturing data packages in the context of development support programmes, such as the PRIority MEdicines scheme (PRIME) in the EU and Breakthrough Therapy designation programme in the US. The goal is to help patients to benefit as early as possible from these therapies that target serious or life-threatening diseases or unmet medical needs.

FDA approves new treatment for patients with acute myeloid leukemia

  • Posted on: 22 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

  • Posted on: 22 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

FDA warns marketers of products labeled as dietary supplements that contain tianeptine

  • Posted on: 22 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration posted warning letter  issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to the FDA of serious adverse events associated with the use of products containing tianeptine.

FDA new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

  • Posted on: 21 November 2018
  • By: Shalini.Sharma

As Commissioner of the U.S. Food and Drug Administration, I remain committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Using the FDA’s labeling tools to foster innovation toward healthier foods that consumers want is one of the primary goals of the FDA’s Nutrition Innovation Strategy that I first announced in March.

FDA approves new drug to treat travelers’ diarrhea

  • Posted on: 20 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.

FDA efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

  • Posted on: 20 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration is committed to animal welfare in research by reducing, replacing and/or refining the use of animals in research, whenever possible.

The aim is this: by doing a single study to help establish a non-animal based model, it can potentially replace much of the need to use dogs in future trials with new informatics tools. The  goal is to do one single study involving a small number of dogs—where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial—to eliminate the need for the use of dogs in certain types of future studies, some where they might have been euthanized.

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

  • Posted on: 20 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year: FDA

  • Posted on: 17 November 2018
  • By: Shalini.Sharma

U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention (CDC) released new findings from the National Youth Tobacco Survey (NYTS) showing that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018, a dramatic increase of more than 1.5 million students since last year. The sharp rise in e-cigarette use has resulted in an increase in overall youth tobacco product use, reversing a decline seen in recent years, and is prompting a series of steps by the FDA to curb youth use trends.

FDA warns StemGenex Biologic Laboratories

  • Posted on: 15 November 2018
  • By: PharmaTutor News

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.

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