Examples of FDA in a sentence
Obe-cel has been granted Orphan Drug Designation by the FDA, Orphan Medical Product Designation by the EMA, Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA and PRIority MEdicines (PRIME) designation by the EMA for adult r/r B-ALL.
ATH434 has been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission.
On the Effective Date, Melior hereby transfers and assigns to Biodexa the IND for the Licensed Product (075144) filed with the FDA by Melior or Bukwang with respect to the Licensed Product and, pursuant to Section 3 below, any information in Melior’s or Bukwang’s control requested by Biodexa and required for Biodexa to take over such IND sponsorship, or reasonably requested by Biodexa with respect to the Development and Manufacture of the Compound and Licensed Product.
The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
These vendors must comply with all applicable international and local healthcare program and regulatory requirements, including the FDA.