An IND application submitted to the FDA can easily run 10 or more volumes, largely consisting of reviews and copies of published studies related to the drug in question. Many of the required documents ...

With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common ...

BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and ...

The U.S. Army Medical Research and Materiel Command's Enterprise Information Technology Project Management Office helped the U.S. Army Medical Materiel Development Activity submit its first in-house ...