Latest Food and Drug Administration Stories
FDA’s new proposed rules will make drug manufacturers revamp the way they register data on ClinicalTrials.gov.
HORSHOLM, Denmark, Dec. 19, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) (Veloxis) today issued the following statement regarding an order issued by the U.S.
Implants constructed from a novel porous resorbable biomaterial offer surgeons an attractive alternative to allograft WOBURN, Mass., Dec.
Increasingly FDA warning letters to GMP facilities cite violations in raw materials management.
Expects Rapid Penetration of $70m Rimadyl(R) Chewable Tablets Market PORTLAND, Maine, Dec.
Biohaven filed a pre-IND meeting request with the FDA regarding lead investigational agent BHV-0223, receives written response in lieu of an in-person meeting TORONTO, Dec.
Biosimilar stakeholders urge the FDA to pass final regulations related to the drugs at a recent conference on biosimilars, reports Atlantic Information Services’ Specialty Pharmacy News in its
Power morcellators first came to market decades ago, under the FDA’s 510(k) clearance program, which in most cases does not require controlled human testing. New
OAKLAND, Calif. and NEW YORK, Dec.
Believed to be the First Company to Have a Biosimilar Filing Accepted for Review of Amgen's Neulasta® TORONTO, Dec.
Flavr Savr, also known as CGN-89564, a genetically modified tomato, was the first commercially grown genetically engineered food to be granted a license for human consumption. It was produced by the Californian company Calgene, and submitted to the U.S. Food and Drug Administration in 1992. On May 18, 1994, the FDA completed its evaluation of the Flavr Savr tomato and the usage of APH(3’)II, concluding that the tomato “is as safe as tomatoes bred by conventional means” and “that the...
The Chilean sea bass is the North American name for the Patagonian toothfish. The Chilean sea bass name derived in 1977 from Lee Lantz, a fish wholesaler looking for a more attractive name for the American fish market. In 1994 the Food and Drug Administration (FDA) accepted the Chilean sea bass as an alternative name for the Patagonian toothfish. This species is native to the southern Pacific, Atlantic, and Indian Oceans, around seamounts and continental shelves in the colder waters. The...
- A volcanic mudflow.