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Analysis of Post-Change Comparability and PEGylation Among Biotech CMC Concerns Drawing FDA Comment at AAPS National Biotech Conference

The expectations for pre- and post-change lot comparisons and for PEGylation analysis were among FDA CMC application filing concerns addressed by CDER Office of Biotechnology Products (OBP) official Susan Kirschner at an “ask the regulator” session at AAPS’ National Biotech Conference in late May in San Diego, California....

EMA’s Biotech CMC Focal Points Include Biosimilar Guideline Revisions and Joint Reviews with FDA

EMA is nearing release of revised drafts of its biosimilars guidelines to reflect experience gained and stakeholder input and is refining its cooperative application review process with FDA – two of the European agency’s focal points in the biotech CMC arena....

EMA’s Finalized Biological IMP Quality Guideline Furthers European Clinical and Biotech Review Harmonization

EMA’s finalized guideline on “the requirements for quality documentation concerning biological investigational medicinal products in clinical trials” reflects significant changes made to the draft resulting from extensive industry/regulator dialogue and marks an important step in the agency’s efforts to harmonize requirements in the clinical and biotech arenas across Europe....

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....

FDA Commissioner Hamburg Highlights the Role of FDA and Regulatory Science in Drug Innovation

In a compelling speech delivered at the Commonwealth Club of San Francisco in early February, FDA Commissioner Margaret Hamburg cited the approvals of three innovative drugs over the previous month – Genentech’s Erivedge, Vertex’s Kalydeco, and BTG’s Voraxaze – as examples of how the agency is using the advancing regulatory science to create a more flexible and innovation-supportive process that “swiftly and surely reviews product applications that come before us.”....

Genzyme Viral Contamination Lessons Implemented in New Biotech Plant; Virus Control Draws Agency/Industry Dialogue

FDA’s and EMA’s January inspection clearance of Genzyme’s new production facility in Framingham, Massachusetts marks another significant step in the firm’s recovery process from a viral contamination and GMP compliance problems cited in a consent decree....

FDA Releases Biosimilar Authorization Performance Goals for Comment as Efforts to Implement the New Act Continue

FDA has released for comment a draft of its 2012-2017 performance goals for authorizing biosimilar products as called for under the terms of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Comments are due by January 6, 2012....

Brazil’s ANVISA Establishes Biological Medicines Office

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FDA Commissioner Outlines Steps to Spur Biomedical Innovation

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EMA Plans Revisions to Influenza Vaccine Guidance

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