In 1994, DuPont Merck submitted 179 periodic new drug application safety reports, either annually or quarterly, for 170 products and 104 annual investigational new drug applications, producing a total of 283 periodic safety reports
Christoffersen said the collaborators identified a number of ribozymes that potentially could be taken forward, but he declined to discuss the status of the candidates or project timetables on the filing of an investigational new drug application
Under the Hatch-Waxman amendments, pharmaceutical companies seeking to market pioneer drugs must first obtain FDA approval through the filing of a new drug application (NDA
Instead of letting several people be in charge, the center will designate one official for a manufacturer to deal with on a particular issue, similar to the designated official in charge of a new drug application, Zoon said
The deal, including clinical developments costs, is worth about $70 million to Cytel assuming Cylexin is brought to the new drug application stage in the initial indication of acute myocardial infarction, said Deborah Goode, the company's director of business development
Endocon Inc., of South Walpole, Mass., and Apollo Genetics Inc., of Cambridge, Mass., filed an investigational new drug application with the FDA to begin Phase I trials of Neurestrol
Pediatric neurologist Larry Powe, who directs central nervous system clinical research at RPR in Collegeville, explained that registration dossiers submitted to European health authorities are the equivalent of new drug applications filed with the U.S. Food and Drug Administration
Craig Smith, president and CEO of Baltimore-based Guilford, said the company plans to submit a treatment investigational new drug (IND) application in the third quarter, and a new drug application (NDA) in the fourth quarter this year
A special committee of ICN Pharmaceuticals Inc.'s board of directors cleared the company and its chairman and CEO, Milan Panic, of any inappropriate or misleading actions related to the FDA's rejection last November of a new drug application (NDA) for Virazole, an antiviral agent for hepatitis C
Diatech Inc., of Londonderry, N.H., submitted an investigational new drug application to the FDA to begin clinical trials of Techtide, a technetium-99m labeled synthetic peptide, for detection of infections of unknown origin
investigational new drug application