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EMA Veterinary Novel Therapies

In mid-December, EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) established an expert group on novel veterinary therapies. The expert group will work to provide guidance on the new classes of veterinary medicines, such as stem-cell therapies and monoclonal antibodies (MAbs). The group was formed due to the need for guidance on novel concepts […]

FDA on Removing Duplicative BLA Requirements

In mid-August, FDA issued a proposed rule on removing §§ 610.11, 610.11a, and 680.3(b) – regulations that require manufacturers of biological products to perform a specified test for general safety of biological products. FDA explained in its Federal Register announcement that these regulations are “duplicative, outmoded, or are otherwise unnecessary” in assuring safety, purity, and […]

International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products....

Global Quality Regulatory Maze Jeopardizes Vaccine Supply, IFPMA is Stressing

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) is throwing a spotlight on the impact that the current tangled global regulatory web is having on the ability to supply vaccines to the people who need them....

Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum

Industry associations have been meeting with Japanese regulators to highlight the problems they are experiencing in Japan’s process for regulating post-approval manufacturing changes, including a lack of flexibility around biotech product changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations....

Top Analytical Method Problems in INDs and BLAs Include Not Enough Detail for FDA Replication and Inadequate Suitability Controls

Insufficient detail to allow FDA to replicate an analytical method, and failure to include appropriate system suitability controls, are two prominent analytical method problem areas that FDA is finding in reviewing investigational new drug (IND) and biologic license application (BLA) submissions....

A Well-Thought-Out Immunogenicity Clinical Evaluation is Needed to Overcome Prediction Limitations for MAbs, NIBSC Expert Cautions

A well-thought-out clinical evaluation of the immunogenicity of monoclonal antibodies is a critical component of the regulatory clearance pathway and making predictions and generalizations short of this clinical analysis is dangerous, UK’s National Institute for Biological Standards and Control Biotherapeutics Group Head Robin Thorpe cautioned the attendees at a PDA MAb workshop in Basel, Switzerland in September....

CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development

Initiatives that will be on the front burner at the Center for Biologics Evaluation and Research (CBER) over the next year include: ● the completion of an electronic export certification system ● the increased use of databases to identify and confirm adverse events with vaccines and blood products, and ● using its extensive laboratory facilities and expertise to help in the development of novel products....

Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree

Regulators are highlighting a better understanding of protein glycosylation – its linkage to product safety and efficacy and what constitutes appropriate characterization – as an important element in developing a more internationally-aligned approach to regulating biotech products....

MedImmune’s Agreement to Produce Merck’s Biosimilars Exemplifies Shifting Biotech Manufacturing Sands

MedImmune’s long-term, “trusted partner” agreement with Merck to produce Merck's biosimilars exemplifies the shifting sands of biotech production capability and need and the different relationships that are being explored to handle that flux....
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