FDA Approvals - UPDATE 1-FDA denies expanded Avodart OK for now -Glaxo *
UPDATE 1-FDA denies expanded Avodart OK for now -Glaxo
* Says received complete response letter for new use * Did not specify FDA concerns * Rejection does not affect current Avodart approvals NEW YORK, Jan 26 (Reuters) - U.S. health regulatorsdeclined to ...
Fourth FDA Orphan Drug Designation Workshop Scheduled For Feb. 28 - March 1, 2011
The U.S. Food and Drug Administration has scheduled its fourth orphan drug designation workshop for academics, biotechnology companies, and those unfamiliar with the process for Feb. 28 - March 1, 2011, in Claremont, Calif. in collaboration with Keck Graduate Institute. The workshop, co-sponsored by the National Organization of Rare Disorders and the Genetic Alliance, will focus on the process ...