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FDA Data Integrity Findings Continue at Indian Firms, Highlighting Challenges in Changing a Facility’s Quality Culture

FDA investigators are continuing to uncover serious data integrity issues at facilities in India, including repeat citations – highlighting the challenges regulators face in getting companies to make changes in their quality culture....

IPQ Monthly Update, November/December 2013

In focus is the transformation underway in FDA’s generics program under GDUFA, the agency’s implementation of the compounding provisions of the DQSA legislation, and the regulator/industry effort to tighten the quality/clinical connection….

Interactions Between OGD’s Inactive Ingredients Database Working Group and IPEC on IID Content and Functionality Bearing Fruit

The cooperative effort between FDA’s Inactive Ingredients Database (IID) Working Group and the International Pharmaceutical Excipients Council (IPEC) to improve the IID’s content and functionality is beginning to bear fruit and will gain further momentum from the extra resources that will become available to the Office of Generic Drugs (OGD) to support projects that meet the Generic Drug User Fee Act (GDUFA) goals of creating a more efficient review process....

Transformation in Industry Practice Must Accompany FDA’s Generics Program Overhaul to Meet GDUFA Goals, OGD Stresses

A core message emerging from the presentations by FDA management at the GPhA/FDA Fall Technical Conference in Bethesda, MD in late October is that the transformation underway in the agency’s generic drug review program will need to be matched by an equivalent transformation in industry practice for the goals of the Generic Drug User Fee Act (GDUFA) to be achieved....

FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....

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....

FDASIA Implementation and a Sharpened Focus on Quality Head Center for Drugs’ Agenda

The impact of the Food and Drug Administration Safety and Innovation Act (FDASIA) on the Center for Drug Evaluation and Research (CDER) is beginning to be felt as the center comes to grips with implementing the requirements of the Act and the organizational effort it will take to meet them....

The Accelerated Recovery Initiative on Drug Shortages is Gaining Momentum – Pilot Program Underway

The Accelerated Recovery Initiative (ARI) – an FDA/industry partnership being coordinated by pharma data manager IMS – is gaining momentum in its effort to forecast, prevent, and mitigate the impact of drug shortages, and a pilot program is now underway....

FDA Investigators Checking Hospira’s Remediation Progress

In a Feb. 13 call with investors following Hospira’s release of fourth quarter financial results, CEO Michael Ball indicated that FDA was currently inspecting the Rocky Mount plant.  He noted that the company has allocated about $375 million for its remediation efforts, including covering tens of thousands of hours for consultants and has been slowly […]
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