Susan Shockey

2 months ago | outsourcedpharma.com | Susan Shockey |Louis Garguilo

Guest Column | February 14, 2025 By Susan Shockey, Clarkston Consulting The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025.1 The FDA stated in the federal register announcement2 that it recognizes that the use of artificial intelligence (AI) in drug development is broad and rapidly evolving.

Jan 16, 2025 | cellandgene.com | Susan Shockey

By Susan Shockey, Clarkston Consulting Cellular and gene therapy (CGT) development areas have been increasingly active, and the approval pipeline for CGT products continues to grow.

Jun 20, 2024 | biosimilardevelopment.com | Susan Shockey |Tim Sandle |Gunjan Bagla

Get more biosimilar development insight with our FREE newsletter Newsletter | June 20, 2024 Register by 17 July to Save up to 20% The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good...

May 24, 2024 | pharmaceuticalonline.com | Susan Shockey

By Susan Shockey, Clarkston Consulting The U.S. FDA has long been concerned with integrity of data related to GMP processes and documentation, including data submitted as part of applications for approvals. This focus has recently been extended to specifically address integrity of the data for bioavailability (BA) and bioequivalence (BE) studies submitted as part of applications for approvals in new drug applications and biologic license applications.

Nov 29, 2023 | outsourcedpharma.com | Louis Garguilo |Susan Shockey |Justin A. Divan

Join The Advancing RNA CommunityIntroducing Advancing RNA, an online community designed to be a forum and resource for professionals working on RNA-based therapeutics to better understand the challenges that confront them in areas including analytical/quality, manufacturing, formulation, outsourcing, clinical research, and supply chain/logistics. Sign up for the Advancing RNA newsletter, delivered to your inbox weekly.