Industry News
FDA Commissioner Outlines New Step for Stronger Drug Manufacturing Oversight
September 1st 2017A new collaboration between CDER and ORA will more fully integrate drug review programs with facility evaluations and inspections, in an effort to streamline drug reviews while strengthening manufacturing oversight.
FDA Commissioner Issues Statement on New Stem-Cell Therapy and Regenerative Meds Policy
August 28th 2017FDA issues a statement on new policy and enforcement steps to ensure proper oversight of stem cell therapies and regenerative medicine in the wake of two incidents involving unauthorized stem-cell treatment activity.
Industry Workgroup Examines Exposure Limit Data
August 24th 2017An industry workgroup made up of pharmaceutical companies, toxicologists, and data experts plans to unveil the early results of a data sharing project designed to enhance the safety of drug substances and aid compliance with quality guidelines, such as ICH M7.