USFDA

FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

  • Posted on: 18 November 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older.

FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

  • Posted on: 18 November 2019
  • By: Shalini.Sharma

Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, and microorganisms such as bacteria or yeast, and developed using advanced science. They are usually more complex than other drugs and are particularly critical in the treatment of cancer and autoimmune conditions, such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.

FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

  • Posted on: 8 November 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S.

FDA efforts to protect patients through postmarket drug safety surveillance practices

  • Posted on: 8 November 2019
  • By: Shalini.Sharma

Public health and safety is the highest priority at the U.S. Food and Drug Administration. We maintain a robust practice of postmarket surveillance and risk evaluation programs to identify new adverse events that did not appear during the product development process, or to learn more about known adverse events. Evaluations occur on more than two million adverse event reports submitted every year to the FDA Adverse Event Reporting System (FAERS) through the MedWatch Program and to the Vaccine Adverse Event Reporting System (VAERS) by patients, family members, and health care providers, as well as adverse event reports submitted by regulated industry. Staff in our Office of Surveillance and Epidemiology and CBER’s Office of Biostatistics and Epidemiology use this information to identify safety concerns and recommend actions to improve product safety and protect the public.

USDA, EPA and FDA announce partnership with the Food Waste Reduction Alliance

  • Posted on: 1 November 2019
  • By: Shalini.Sharma

U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) announced a new partnership with the Food Waste Reduction Alliance, the latest effort in the Winning on Reducing Food Waste Initiative launched by the three federal agencies in 2018.

FDA grants first-ever modified risk orders to eight smokeless tobacco products

  • Posted on: 24 October 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration announced that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.

FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease

  • Posted on: 24 October 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.

FDA continued progress enhancing patient access to high-quality, low-cost generic drugs

  • Posted on: 19 October 2019
  • By: Shalini.Sharma

Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion.

FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

  • Posted on: 14 October 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.

FDA awards two grants for natural history studies in rare diseases

  • Posted on: 11 October 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  announced it has awarded two new research grants for natural history studies in rare diseases. The FDA is providing over $4.1 million over the next four years to fund these studies. Information from natural history studies can facilitate design of efficient clinical trials to test future treatments.

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