Humans possess several well-established bodily systems, including the sympathetic nervous system, the central nervous system, and the endocrine system. A relatively recent discovery is the endocannabinoid system (ECS)....more
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act”...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
Report on Research Compliance 17, no. 12 (December 2020) - Finalizing a document issued last year, on Nov. 9 the Food and Drug Administration issued “Enhancing the Diversity of Clinical Trial Populations—Eligibility...more
Requirement for a Pediatric Clinical Investigation - Starting on August 18, 2020, any drug company submitting an original application for a first-to-be approved or licensed cancer drug that: - is indicated for an adult...more