Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for Insulin (Dec 4, 2019 21:30)
By Sara W. Koblitz —

HPM Congratulates Two New Directors, Deborah L. Livornese and Serra J. Schlanger (Dec 3, 2019 22:08)


FDA’s Latest Draft Guidance on Compounding Animal Drugs From Bulk Substances Seeks Industry Input! Comments Due on February 18, 2020 (Dec 2, 2019 22:50)
By Karla L. Palmer —

FDA Releases Revised Draft Guidance on Compounding Animal Drugs from Bulk Substances, and Seeks to Create an Animal “Bulks” List Through a Substance Nomination Process (Dec 1, 2019 22:31)
By Karla L. Palmer —

CHPA Petitions FDA to Swiftly Establish a Clear Path for CBD in Dietary Supplements (Nov 27, 2019 02:20)
By Riëtte van Laack —

Too Much, Too Soon: OPDP Issues Untitled Letter for Pre-approval Promotion (Nov 25, 2019 02:49)
By Deborah L. Livornese & Dara Katcher Levy —

Novel Clinical Trial Designs for Gene Therapies: An Exploration of Challenges by the National Academies’ Forum on Regenerative Medicine (Nov 21, 2019 20:19)
By Sarah Wicks & James E. Valentine & Frank J. Sasinowski —

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