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Thai FDA to Accept eCTD

In late August, the Thai FDA released draft criteria for the specification and validation of eCTD submissions. The agency is accepting pilot submissions starting in mid-October and plans to accept eCTDs officially by May 2015.

IPEC and IQ Consortium Team Up to Push for an Independent Pathway for New Excipient Review

A call to action is reverberating through the pharmaceutical community for the establishment of a viable regulatory pathway for new or modified excipients, which would empower industry to develop more quality-by-design-based formulations....

IPQ Monthly Update, May 2014

Encompassed in IPQ’s May coverage are in-depth analyses of: ● the evolving excipient regulatory approaches in the U.S. and around the world and the role DMFs are playing ● FDA’s compliance/enforcement data transparency initiative and why it is high on the agency’s agenda ● the UK initiative to refocus its GMP enforcement efforts through more intelligence gathering, and ● finalized guidances from FDA and EMA to help post-approval change management....

Top Excipient DMF Problem Areas for FDA Include Authorization Letters, Paper Filings, and Annual Reports

FDA wants the excipient industry to better understand the challenges that the agency faces in reviewing drug master files (DMFs) and to improve their filings so that they do not impede the drug application process....

China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades

China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight....

CDER Releases Q&A on Stability Testing for ANDAs

In mid-May, CDER’s generics office issued a Q&A “to more effectively address the public comments” related to the September 2012 draft guidance on “ANDAs: Stability Testing of Drug Substances and Products” (see IPQ Sept. 10, 2012). The Q&A is organized into a general section and specific sections addressing drug master files, drug product manufacturing and […]

Health Canada Releases Draft Guidance on Drug Quality Submissions

Health Canada released a draft guidance in late January that updates its expectations for New and Abbreviated New Drug Submissions based on current ICH guidelines including ICH’s guidance on quality by design (QbD). Other primary changes involve HC’s current interpretation of Canada’s food and drug regulations and clarification and expansion of the type of information […]

FDA is Working to Expand Question-Based Review Approach From Generic to Innovator Applications

A working group that spans the new drug and generic reviewing offices at FDA’s Center for Drug Evaluation and Research (CDER) is nearing release of a proposed revision of the questions it developed under its question-based review (QbR) approach for generics that is designed to be applied to innovator applications as well....

FDA’s Center for Drugs Redoubles Effort to Achieve 21st Century Quality Vision and Foster Continuous Process Improvement

FDA’s Center for Drug Evaluation and Research (CDER) is wrestling with how to reshape its quality regulatory system to foster rather than impede continuous improvement across the lifecycle of a process....

Changes to OGD’s API DMF Process Target Submission Quality and Review Streamlining

Significant changes are being made by FDA’s Office of Generic Drugs (OGD) to its active ingredient Drug Master File (DMF) review program to improve the quality of industry submissions and streamline the review process so that DMFs are not a rate-limiting factor in ANDA clearance....
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