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FDA Releases Guidance on Q4B Evaluation

In mid-June, FDA announced the availability of a final guidance entitled, “Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 6: Uniformity of Dosage Units General Chapter.” The guidance provides evaluation results from the ICH Q4B General Chapter harmonized text and is in the form of an […]

EMA Revising Applications/Advice Procedures

In late March, EMA announced a revision to its procedures for application submission and for advice requests that reflects a structural reorganization in September 2013. The changes, one of which relates to the EMA contact persons, will be implemented for new applications submitted as of April 1, 2014. For ongoing applications a transition plan has […]

EMA to Launch Drug Approval Fast-track

EMA announced in mid-March that it will launch a fast-track for drug approval termed the “adaptive licensing pilot project.” Like FDAs breakthrough therapy pathway (IPQ September 26, 2013), the program is intended to grant early access for medicines meant to treat unmet needs. Companies who are interested in participating in the pilot are requested to […]

IPQ Monthly Update, January 2014

In focus in IPQ’s Update for January are: ● the efforts by biotech product manufacturers to get a better grip on the quality/immunogenicity relationship ● the current FDA drug compliance office priorities – including the implementation of DQSA, FDASIA and CDER reorganizing to advance quality oversight, and ● the top problem areas FDA reviewers are seeing in analytical method filings and their advice on how to avoid them....

Health Canada Releases Draft Guidance on Drug Quality Submissions

Health Canada released a draft guidance in late January that updates its expectations for New and Abbreviated New Drug Submissions based on current ICH guidelines including ICH’s guidance on quality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 […]

U.S./Canada Common Electronic Submissions Gateway

The US and Canada have agreed to a common platform for medical product applications that will allow for their mutual electronic submission in the two countries (link to FDA announcement).

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....

IPQ Monthly Update, June 2013

FDA’s center for drugs recognizes that deeper changes to the quality regulatory paradigm are needed to realize the vision embodied in the 21st Century initiative a decade ago of a pharmaceutical industry set on a pathway of continuous process improvement throughout the product lifecycle....

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 Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System

FDA is proposing that the application of the right quality metrics could help create a more flexible and rationalized review and inspection system and is asking for industry input on what metrics would provide the most effective leverage....
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