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Initiatives to Strengthen FDA’s Generic Drug Review Process Include OGD Supplement and Peptide Teams

FDA’s Office of Generic Drugs (OGD) has created dedicated teams for the review of supplements and peptide drugs as part of an office-wide effort to improve the efficiency and effectiveness of its review processes and explore where policy and resource improvements are needed....

Several Drug Substance Guideline Initiatives Moving Forward in Europe and ICH

Europe and ICH have several guideline initiatives underway that will help clarify and harmonize the regulatory expectations for drug substances and the control of their impurities....

ICH Q11 Nears Final Approval After Comments Prompt Changes in Step 2 Draft

The final version of ICH’s drug substance development and manufacturing guideline Q11 is nearing Step 4 clearance by the regulatory agencies in the three ICH regions following some significant changes the Expert Working Group (EWG) has made to the Step 2 draft based on the comments received....

China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....

Value of Attribute Risk Ranking in Process Development Recognized by ICH Q11 EWG

The current working draft of ICH Q11 promotes the use of risk ranking of quality attributes as a valuable tool in applying quality-by-design (QbD) principles to biotech drug substance development and manufacturing....

ICH Q11 Process Validation Discussion Will Be at High Level Given Guideline’s Scope

The ICH Q11 Expert Working Group (EWG) is settling on a high level approach to addressing process validation in its drug substance development and manufacturing guideline, reflecting the challenges of encompassing drug and biotech products and the evolving expectations across the three regions....

ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components

The lifecycle management section of the newest working draft of ICH’s Q11 guideline on drug substance development and manufacturing provides allowance for applicants to include change management proposals in their original submissions....

ICH Q11 Guideline Structure and Content Taking Shape

The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline’s breadth and depth and its relationship to the other guidelines in the ICH quality family....

Regulatory Transparency vs. Industry Flexibility at Issue for Starting Materials in ICH Q11

The ICH Q11 Expert Working Group (EWG) has been wrestling with balancing regulatory transparency with industry flexibility in defining the starting material as it moves forward in drafting the guideline on drug substance development and manufacturing....
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