BIO provides general comments and recommendations to FDA on “Complying with the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act” (Docket No. FDA-2005-D-0460-0007)
Letters, Testimony & Comments | July 17, 2023 | FDA Review, FDA Guidance, FDA Regulations
BIO provides general comments and recommendations on FDA’s Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act (Docket No. FDA-2005-D-0460-0008)
Letters, Testimony & Comments | July 10, 2023 | Human Health, Policy & Regulatory
BIO provides detailed comments to the Committee on its draft of the 2023 Reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), legislation that is critical to our national health security.
BIO and 59 other organizations have written to House and Senate Agriculture Committee leaders to ask that they direct Congress to withdraw the current rule concerning regulation of plant incorporated protectants and replace it one based on a science-based consideration of the risks and benefits of…
Letters, Testimony & Comments | June 29, 2023 | Drug Development Process, Patient Advocacy
BIO comments to the Office of Management & Budget in response to the agency’s request for information on measuring and classifying the bioeconomy for potential inclusion in the North American Industry Classification System (NAICS) and North American Product Classification System (NAPCS).