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Preparing for and Communicating Manufacturing Changes During Late Stage Development Smoothes Biotech Clearance Process with FDA

Comparability studies for changes which inevitably occur during Phases II and III for biotech products must be planned for by the firms conducting them, FDA is stressing. The agency is also cautioning that communication with FDA during the end-of-Phase-II and pre-Biologic License Application (BLA) meetings and through the submission and preapproval inspection important to understand common expectations and make it easier to work through issues that will arise due to these changes....

CBER Releases Updated Compliance Program Guide on Inspection of Biological Drug Products

The Center for Biologics Evaluation and Research (CBER) released in June a revised version of its Compliance Program Guidance (CPG) 7345.848, “Inspection of Biological Drug Products,” which combines and replaces previous versions of CPGs covering related biological products and provides inspectional guidance to investigators for conducting biennial or for-cause inspections across the biologics spectrum....

FDA Seeing Wide Variation in Drug Application Manufacturing Submissions, Causing Approval Delays

Manufacturing information that is inaccurate, incomplete, inconsistent, or in the wrong section in new and abbreviated new drug applications (NDAs/ANDAs) as well as facilities not being ready for an inspection continue to be problem areas causing delays in application approvals, Center for Drug Evaluation and Research (CDER) officials are reporting....

Genzyme Allston Plant Resumes Normal Operations Although Shortages Continue

In a June 29 update, Genzyme clarified its current production status and the impact remediation efforts are having on its ability to release product and supply the market....

New FDA Draft Guidance Reduces Reporting Burden for CMC Postapproval Changes

A new draft guidance from FDA specifies 40 types of low-risk manufacturing changes that will now quality for annual report filing and represents a significant step in the agency’s effort to reduce the number of supplements that have to funnel through the Center for Drug Evaluation and Research (CDER) clearance process....

USP Upgrading Bioassay Coverage; FDA Weighs In on Bioassays at AAPS’ National Biotech Meeting

The US Pharmacopeia (USP) is upgrading its coverage related to bioassays to keep pace with the evolving science and technology. In its July/August Pharmacopeial Forum, USP is proposing revisions for public comment to General Chapters <1032>, <1033>, and <1034>, which address the design, validation, and analysis of bioassays respectively....

Consulting Firms Are Busy in Wake of Stronger FDA Enforcement, Lachman’s Sturgeon Reports

Heightened scrutiny of drug manufacturers by FDA has led to an increase in warning letters, injunctions, and import alerts, and in turn has significantly increased the demand for consulting services, Lachman Consultants’ President Roy Sturgeon told the participants in an investor “conference call” sponsored by New York-based Lazard Capital Markets on June 22....

FDA Tabling Public Biosimilar Discussions While Digesting Complexities of New Legislation

FDA speakers at recent conferences have been open about their inability to discuss biosimilar issues at this time, while they digest the implications of the recently-passed Patient Protection and Affordable Care Act (PPACA)....

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....

FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape

FDA is fast-tracking a set of changes to 21 CFR Part 211 targeting control of raw materials, excipients and components used in pharmaceutical manufacturing. Also being completed are changes impacting management responsibilities, self-inspections, defect investigations, change control, training documentation, and use of purified water in manufacturing....
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