USFDA

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

U.S. Food and Drug Administration announced its new export certification program for certain FDA-regulated food products and fees it will assess for issuing new export certifications to U.S.-based manufacturers or exporters of these products. Export certification under the Federal Food, Drug & Cosmetic Act (FD&C Act) provides U.S. exporters another tool to facilitate exports to countries that import food products from the U.S.

This guidance provides recommendations to industry on the development of a shared system risk evaluation and mitigation strategy (REMS) for multiple prescription drug (including biological) products.

Ensuring that food is safe and truthfully labeled is one of our fundamental responsibilities at the U.S. Food and Drug Administration. Consumers deserve accurate information about the food they eat and how it can affect their health and nutrition. That’s why Congress entrusted the FDA to serve as the nation’s expert on food safety and labeling and to craft predictable, uniform federal requirements on matters within our jurisdiction. Consistent with that authority, we work to provide the best advice possible to Americans about the foods they eat based on the most recent scientific information, taking into account the food’s benefits in addition to any potential health risks.

The U.S. Food and Drug Administration announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers.

The U.S. Food and Drug Administration  approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

In a strategic move, Cadila Healthcare Limited (CHL), a leading global healthcare provider announced that it will be acquiring 51% stake in Dehradun-based Windlas Healthcare Private Limited (WHPL).

U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD).

As the field advances, the U.S. Food and Drug Administration is playing a key role in sorting through the science and the science fiction of this evolving field.

Over the last several years, there’s been growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease. Consumers are familiar with the phrase “good” or “helpful” bacteria and the expectation that it will aid in treating or preventing various illnesses.