Latest Federal Register Notices
Draft Guide on Drug Starting Materials
Federal Register Notice: FDA has made available a draft guidance entitled “Q11 Development and Manufacture of Drug Substances — Questions and Answers (regarding the selection and justification of starting materials).” The International Council for Harmonization guidance is intended to clarify the principles for selecting starting materials. It focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and Master Files to justify the starting materials. To view the guidance, click here. To view the notice, click here.
Docket Established for Pediatric Postmarketing Reviews
Federal Register Notice: FDA has established a public docket to collect comments related to pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between 9/17/2016 and 2/24/2017 on the agency’s Web site, but will not be presented at a 3/6-7 Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public. To view the reviews, click here. To view the notice, click here.
FDA Debars Raymond Brown Over Foreign-Sourced Botox
Federal Register Notice: FDA has issued an order to permanently debar Raymond Sean Brown from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Brown was convicted of a felony under federal law for conduct relating to the regulation of a drug product. Brown had purchased foreign-sourced Botox for use in his Tennessee practice, and billed Medicare for all of these Botox units as if they were FDA-approved drugs. To view the notice, click here.
FDA Debarment Order Against Karis Delong
Federal Register Notice: FDA has issued an order debarring Karis Copper Delong for a period of 12 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Delong was convicted of four misdemeanor counts under the FD&C Act for introducing, delivering for introduction, and causing the introduction and delivery for introduction of a misbranded drug into interstate commerce. To view the notice, click here.
FDA/Xavier Host Conference on Global Supply Chain
Federal Register Notice: FDA’s Cincinnati District is co-sponsoring with Xavier University a public conference 3/15-17 entitled ‘“FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.” Topics to be discussed include How Big Data and Artificial Intelligence Can Enhance Your Proactive Risk Monitoring Programs; Connecting Culture to Performance; Building a Bridge Across Generations; and Good Supply Practices — Paradigm Shifting Solutions. The conference will be held on the campus of Xavier University in Cincinnati, OH 4520. To view the notice, click here.