USFDA

FDA alerting patients and health care professionals of NDMA found in samples of ranitidine

  • Posted on: 16 September 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

  • Posted on: 30 August 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes. An "off" episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking.

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

  • Posted on: 22 August 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including data integrity issues.

EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US

  • Posted on: 22 August 2019
  • By: Shalini.Sharma

EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines.

FDA warns consumers about the dangerous and potentially life threating side effects of Miracle Mineral Solution

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

The U.S. Food and Drug Administration is warning consumers not to purchase or drink a product sold online as a medical treatment due to a recent rise in reported health issues. Since 2010, the FDA has warned External Link Disclaimer consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide (CD) Protocol, Water Purification Solution (WPS) and other similar products. Miracle Mineral Solution has not been approved by the FDA for any use, but these products continue to be promoted on social media as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. However, the solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects.

FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses

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

U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.

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