Learn how to establish global drug substance and drug product specifications that are appropriate to the phase of clinical development and market application, and understand the types of data that are ...

Market opportunities include providing training for analytical method validation, offering services for the transfer and verification of analytical procedures, developing compendial coordination ...

The Food and Drug Administration (“FDA”) has released draft interim guidance documents that impact the use of bulk drug substances in compounding under Sections 503A and 503B of the Federal Food, Drug ...

Reata RETA announced that the FDA has accepted the Prior Approval Supplement (PAS) to update the drug substance specification for Skyclarys (omaveloxolone). In February 2023, the company received FDA ...