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The News in Depth

International Joint API Inspection Pilot Program Sees Positive Results

The international API pilot joint inspection program involving regulatory authorities in the EU, US, and Australia is resulting in rapid sharing of inspection reports for non-compliant sites, follow-up inspections at other facilities owned by the companies found to have non-compliant sites, and prompt notification of regulatory actions taken....

Facility Listing Errors and Missing Development Data Draw Withhold Recommendations From FDA’s NJ District

Facility listing errors on the application and a lack of availability of development data source documents during pre-approval inspections are causing the New Jersey District to recommend withholding drug approvals, its investigations branch director Myriam Sosa told DIA’s June Annual Meeting....

Communication Between CMC and Clinical Groups is Key in IND Phase, FDA says

FDA Center for Drug Evaluation and Research (CDER) is stressing that communication problems between the CMC and clinical groups working in Phase I can result in important risks not being identified and can impede IND/Phase I progress....

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 process.is important to understand common expectations and make it easier to work through issues that will arise due to these changes....

The New IPQ Publication “Monthly Update” is Now Available

Now available, the inaugural issue of IPQ’s “Monthly Update” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications has been expanded this Spring to include breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.” These now accompany our uniquely valuable in-depth “Special Reports” on emerging areas of concern drawing particular attention from industry and regulators....

ICH Q11 Guideline Structure and Content Taking Shape

The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guideline’s breadth and depth and its relationship to the other guidelines in the ICH quality family....

Regulatory Transparency vs. Industry Flexibility at Issue for Starting Materials in ICH Q11

The ICH Q11 Expert Working Group (EWG) has been wrestling with balancing regulatory transparency with industry flexibility in defining the starting material as it moves forward in drafting the guideline on drug substance development and manufacturing....

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....

Regulatory Import of Non-critical Parameters Among Issues Under Debate at ICH Q8-10 Workshop

The expectations for non-critical parameters in communicating with regulators on process design, control and change management drew significant attention at the ICH Quality Implementation Working Group (IWG) training workshop in Tallinn, Estonia in early June....
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