Newsletter - October 14, 2021
FDA Eases Compounding Rules for Hospitals: Ever So Slightly but Significantly
Pharmacies located within hospitals are not required to register with the FDA as “Outsourcing Facilities” and are exempt from following GMP. However, there are strict conditions for the compounding operations performed at such hospital pharmacies some of which needed clarification and relaxation...Read More
ICH Releases Guidance on QbD Approach for Clinical Development Plans
Clinical trials conducted to support market approval of new drugs must follow a quality by design (QbD) approach where each clinical study, included in the market approval application, identifies factors that were critical to the quality of the study and how those risks were managed during study conduct...Read More
FDA Eases Compounding Rules for Hospitals: Ever So Slightly but Significantly
Pharmacies located within hospitals are not required to register with the FDA as “Outsourcing Facilities” and are exempt from following GMP. However, there are strict conditions for the compounding operations performed at such hospital pharmacies some of which needed clarification and relaxation...Read More
ICH Releases Guidance on QbD Approach for Clinical Development Plans
Clinical trials conducted to support market approval of new drugs must follow a quality by design (QbD) approach where each clinical study, included in the market approval application, identifies factors that were critical to the quality of the study and how those risks were managed during study conduct...Read More
