Newsletter - March 1, 2018
FDA’s Modernized Review Process: Improved Guidance Documents
Last week FDA announced that it is modernizing multiple aspects of its review processes in an effort to make quick decisions, work collaboratively with sponsors and take patient perspectives into consideration for clinical trial design and market approval decisions. To provide examples of its new approach FDA released..Read More
FDA Amends GCP Guideline to Emphasize Quality Responsibilities
Today FDA released an addendum to ICH E6 (R2), the GCP Guidelines, to include several provisions for quality management responsibilities of the sponsors of clinical trials. These additional requirements apply to any trials conducted under an IND or IDE and used to support a US market approval application. Read More
FDA’s Modernized Review Process: Improved Guidance Documents
Last week FDA announced that it is modernizing multiple aspects of its review processes in an effort to make quick decisions, work collaboratively with sponsors and take patient perspectives into consideration for clinical trial design and market approval decisions. To provide examples of its new approach FDA released..Read More
FDA Amends GCP Guideline to Emphasize Quality Responsibilities
Today FDA released an addendum to ICH E6 (R2), the GCP Guidelines, to include several provisions for quality management responsibilities of the sponsors of clinical trials. These additional requirements apply to any trials conducted under an IND or IDE and used to support a US market approval application. Read More
