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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The company filed the regulatory application and allied environmental review for the planned Aspen project with the Alberta Energy Regulator and Alberta Environment and Sustainable Resource Development on Dec.
Nasdaq: DAHI; Toronto) announced today that it has filed its first regulatory application ("New Drug Submission") with the Canadian Health Protection Branch, Bureau of Veterinary Drugs (HPB/BVD), seeking approval to market Anipryl(R) (I-deprenyl, selegiline hydrochloride) for the treatment of canine Cushing's disease.
today announced the submission of a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).
We look forward to gaining approvals of the product throughout Europe with our first regulatory application planned for Sweden within a month, followed by a number of other European applications.
Ligand Pharmaceuticals Incorporated (Nasdaq: LGND), San Diego, has submitted a regulatory application to market its anti-cancer medicine ONZAR(TM) (denileukin diftitox) in the European Union for the treatment of cutaneous T-cell lymphoma (CTCL) patients.
Food and Drug Administration approval, data from this single trial will permit a regulatory application to be filed with the Chinese State Food and Drug Administration (SFDA) in late 2008 or early 2009.
Perth, Australia, May 2, 2012 - (ABN Newswire) - Coalspur Mines Limited (ASX:CPL) (TSE:CPT) is pleased to announce that it has filed the regulatory applications for Phase 1 of the Company's flagship Vista Coal Project ("Vista").
Regulatory applications were submitted by Novartis in 2006 in a number of regions including the European Union, Canada, Australia, Switzerland, Taiwan, South Korea and China seeking marketing approval of telbivudine for the treatment of CHB.
These included a lack of publicly available toxicogenomics databases, a lack of validation of available technologies, questions concerning the comparability of different technical platforms and how transcription products relate to toxicity, and uncertain regulatory applications.
Earlier this year, the Mackenzie Delta Producers Group - Imperial, Conoco Canada, Shell Canada Limited and ExxonMobil Canada, and the Mackenzie Valley Aboriginal Pipeline Corporation (MVAPC) announced plans to begin preparation of regulatory applications needed to develop natural gas resources in the Mackenzie Delta, including a Mackenzie Valley Pipeline.
Earlier this year, the Mackenzie Delta Producers Group--Imperial, Conoco Canada, Shell Canada Limited and ExxonMobil Canada, and the Mackenzie Valley Aboriginal Pipeline Corporation (MVAPC) announced plans to begin preparation of regulatory applications needed to develop natural gas resources in the Mackenzie Delta, including a Mackenzie Valley Pipeline.
Further, Ludeke reports all regulatory applications and approvals are in progress with full approvals expected early in 2002 and construction to start by spring.

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