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Breakage and Particle Problems in Glass Vials and Syringes Spurring Industry Interest in Plastics

Breakage and particle problems associated with glass containers and biologic product sensitivities are prompting pharma firms to take a harder look at polymers for their vials and syringes....

EU Biological Product GMPs Will Expand in Breadth and Depth With New Annex 2

The soon-to-be finalized overhaul of EU GMP Annex 2 will significantly expand the breadth and depth of its coverage of the manufacture of biological products and will bring advanced therapy medicinal products (ATMPs) and those transgenically-derived under its umbrella....

Human Factors/Usability Gaining Prominence in Combination Product Review

Human factors/usability analysis is gaining prominence in the dialogue between combination product manufacturers and regulators. At issue is an effective pathway for companies to follow in conducting and submitting the analysis and for regulators to follow in reviewing it....

More Guidance Forthcoming from FDA’s Office of Combination Products on CMC & GMP Expectations

FDA’s Office of Combination Products (OCP) will be sharing its growing knowledge base through new guidances and updates to its existing library that will help CP manufacturers better understand the regulatory expectations and navigate the shoals of marketing clearance....

Communication with Reviewing Authorities Key to Combination Product Success in Europe and Japan

Communication with reviewing authorities is critical in navigating the combination product regulatory shoals in Europe and Japan as it is in the US. However, the communication channels are not always well-marked, and they differ in each of the three ICH regions....

Risk-based Approach to Combination Products Advocated to Improve Communications with Regulators and Streamline Filing

A risk-based approach could clarify and simplify the regulatory pathway for combination products, Lilly CMC Regulatory Affairs Principle Consultant LeAnn Chambers maintained at a DIA CMC Workshop in February....
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