Legal and Regulatory Legislative Memoranda

Legal and Regulatory Legislative Memoranda

Deemed to Be a License Provision of the Biologics Price Competition- May 13, 2016

Comments on U.S. FDA Guidance entitled "Framework for Regulatory Oversight of Laboratory Developed Tests" - January 28, 2015

Comments on FDA Draft Guidance No. 230- "Guidance of Industry Compounding Animal Drugs from Bulk Drug Substances," August 17, 2015

Comments on "Non Proprietary Naming of Biological Products:Guidance for Industry," October 26, 2015