FDA

How To Use FDA In A Sentence

• By contrast, when Procter & Gamble, the makers of Olestra, asked the FDA for permission to add its artificial fat substitute to potato chips, the controversial product was evaluated under food-additive laws.
• A couple of examples from my own experience at FDA with the review of biopharmaceuticals will illustrate the tension between the regulatory culture and innovation.
• But a tiny, naturally-occurring steviol glycoside constituent (about two to four percent of a whole leaf) of the plant, called rebaudioside A (also known as reb A, rebiana, stevia extract), was passed into Generally Regarded As Safe (GRAS) status by the FDA in 2008. Pooja R. Mottl: Can Stevia Solve Our Obsession With Sweetness?
• Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon's business, including, without limitation, Somaxon's interpretation of its communications and interactions with the FDA relating to the requirements for approval of the NDA for Silenor, and the FDA's agreement with such interpretation; Somaxon's interpretation of the results of the clinical trials for Silenor, the timing of the interpretation of such results and the FDA's agreement with such interpretation; the potential for Somaxon to make a resubmission to the Silenor NDA; the potential for Silenor to receive regulatory approval for one or more indications on a timely basis or at all; the potential for the FDA to impose non-clinical, clinical or other requirements to be completed before or after regulatory approval of Silenor; Somaxon's ability to demonstrate to the satisfaction of the FDA that potential NDA approval of Silenor is appropriate prior to the completion of standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the timing and results of non-clinical studies for Silenor, and the FDA's agreement with Somaxon's interpretation of such results; Digital50.com Digital 50 Daily Industry News RSS Feed
• According to FDA officials, the herb stevia can be ‘adulterated’ merely by being in the presence of information that reveals its sweetening property.
• Pfizer emphasized the halt was limited to patients participating in clinical testing who suffered from a joint disorder known as osteoarthritis, although the company is slated to meet with the FDA later this week to assess any implications for other programs. Pfizer Suspends Trials of Pain Drug After FDA Request
• Meanwhile, in January 1999, FDA rescinded its compliance policy guide that had regulated third-party servicers of medical devices.
• Additionally, FDA officials decided the drug must carry a warning on its label stating, "An increased rate of stroke was observed following Xarelto discontinuation in clinical trials" in patients with the faulty heartbeat known as atrial fibrillation. FDA Approves Anticlotting Drug
• Iron sucrose is a hematinic agent that was recently approved by the FDA for the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving concomitant erythropoietin therapy.
• USFDA applies the technique they used to call organoleptic test. Tips for buying seafood