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BLA CMC Problem Areas Include Lack of Transparency in Supplement Cover Letters, FDA Reports

FDA is urging sponsors filing Biologic License Application (BLA) supplements to clearly highlight the significant changes and their scope in the cover letter to expedite the agency review and approval process....

EMA Releases Q&A on Marketing Authorization Transfers

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Early Attention to Analytical Method Development Can Be Critical to Product Success Later, FDA Cautions

FDA is cautioning firms to pay close attention to analytical method development early in the product lifecycle to avoid the problems the agency is seeing during application review stemming from poorly validated methods....

FDA’s Foreign Office Experience Supports Their Benefit to Global Supply Chain Regulation

FDA’s growing experience with the field offices it has established in India, China and eight other countries is substantiating their benefit in boosting the agency’s efficiency and effectiveness in regulating a global supply chain....

Latin America Diverges Widely on CMC Requirements; Harmonization Effort Continues Through PAHO

While momentum is growing in Latin America for more harmonization around the technical requirements for registering pharmaceuticals, currently there are significant divergences among the countries in the region regarding the expectations for the form and content of CMC submissions....

China’s Quality Regulatory Process Evolving Toward the Western Model

China’s quality regulatory process is evolving toward the Western model as it draws on and incorporates guidance from the EMA, WHO, FDA and ICH....

Australia’s TGA Publishes Updated Draft Guidance on Clearance of Products Manufactured Overseas

TGA has released for comment a draft guideline that clarifies its requirements for GMP compliance by overseas manufacturers and further harmonizes those requirements with other international regulatory bodies....

Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays

A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharma-ceuticals and Biotherapeutics Director Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July....

Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says

The biopharmaceutical regulatory challenges confronting the EMA over the next decade – from biosimilars, advanced therapies, personalized medicine and transgenics to variations and quality by design – will require close industry/regulator dialogue and new communication channels, recently retired EMA Quality of Medicines Head John Purves stressed at CASSS’ European CMC Strategy Forum in Vienna in late May....

FDA Wants to See More Transparency Between Drug Companies and Contractors on Sponsor’s Application and Contractor’s GMP Status

FDA investigators will be looking for more transparency between a sponsor and its contract sites regarding the sponsor’s drug application commitments and the contractor's plant-wide GMP status, FDA Cincinnati District Investigator and Preapproval Manager Kathleen Culver emphasized at a Global Outsourcing Conference at Xavier University on June 14....
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