regulatory application

regulatory application

An application made to a health authority by a drug sponsor to investigate, market or license a new product or indication.
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DBV Resubmits Regulatory Application For Peanut Allergy Drug, Stock Rallies
Swedish biotech company Cyxone (publ) announced on Friday that it filed its first regulatory application with the Central Ethics Committee (CEC) in Poland for permission to start a clinical phase IIb trial with its drug candidate Rabeximod for the treatment of rheumatoid arthritis (RA).
"Each regulatory application that Golden Rice completes with national regulatory agencies takes us one step closer to bringing Golden Rice to the people who need it the most," says IRRI Director General Matthew Morell.
'Each regulatory application that Golden Rice completes with national regulatory agencies takes us one step closer to bringing it to the people who need it the most,' IRRI director general Matthew Morell said.
--"ICCVAM Tools for Validation and Regulatory Application of Alternative Methods" is programmed for Wednesday, March 15, at 1:30 p.m.
In addition, these compliance records can facilitate the design and regulatory application process for medical device OEMs, thereby accelerating product time to market.
"The process with the regulatory application is still ongoing but we are now better equipped to do this and we have a board that will not hesitate to do the right thing for customers."
The project will continue with consultations and regulatory application preparation as previously announced.
is to file a regulatory application for the pipeline shortly.
StatoilHydro ASA (OSE: STL) (NYSE: STO), a Norway-based oil and gas exploration company, has withdrawn a regulatory application for development and construction of a bitumen upgrader in Alberta, Canada.
Submission of a regulatory application, pending the success of the clinical program, is anticipated within three years.
The company says the regulatory application for European approval was based on data from the first 20 patients implanted in its Phase I US trial and in a European study.

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