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The News in Depth

FDA Will Support Efforts to Upgrade Micro Methods and Processes, CDER Reviewer Affirms

FDA Center for Drug Evaluation and Research (CDER) microbiology reviewers are assuring companies that they will be supportive of efforts to upgrade lab methods and manufacturing processes to take advantage of post-approval scientific advancements....

Top Deficiencies Found in CDER’s Micro Review of Regulatory Submissions Include Incomplete Information on Validation of Aseptic and Terminal Processes

Incomplete media fill information for aseptic processes and an inadequate comparison between production and validation conditions for terminal sterilization are among the microbiology concerns in regulatory submissions that most frequently generate information requests and deficiency letters from FDA’s Center for Drug Evaluation and Research (CDER)....

IPQ Monthly Update, June 2014

In focus are: ● FDA’s new process for risk-ranking ANDAs ● an update on other FDA efforts under GDUFA to clarify and streamline its generic drug review process ● the pressure coming from industry to establish an independent review process for new and modified excipients ● advice from FDA compliance experts on proactive GMP communications, and ● the compelling results of Amgen’s eight-year effort to upgrade its nonconformance investigations and follow-up processes to find and address root causes....

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....

FDA Releases Draft Guidance on ANDA Content and Format as Efforts Continue to Clarify and Streamline Review Process Under GDUFA

A draft guidance on the content and format of abbreviated new drug applications (ANDAs) is the most recent effort by the Office of Generic Drugs (OGD) to clarify and streamline the ANDA process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA). The draft was released in mid-June for a 60-day comment period....

FDA Deploys Risk Ranking Process to Streamline ANDA Review

FDA’s generics office has developed a risk assessment algorithm for the review of abbreviated new drug applications (ANDAs) to help address the challenges of balancing more extensive quality-by-design-based submissions with the foreshortened review timelines mandated under the Generic Drug User Fee Act (GDUFA)....

FDASIA Heightens Focus on Proactive Communications with FDA; Timeliness, Accuracy and Transparency are Key, GMP Compliance Experts Advise

The provisions in the FDA Safety and Innovation Act (FDASIA) for communicating with FDA about manufacturing issues that could play out in drug shortages or facilitate regulatory surveillance are heightening industry’s focus on the agency’s expectations for proactive communications....

Success of Eight-Year Amgen Effort to Improve Deviation Investigations and Follow-up Actions Writ Large on Quality Metrics and Bottom Line

The results of an eight-year program at Amgen to improve its deviation investigations and follow-up actions demonstrate how concentrating on finding and addressing root causes can have a substantial impact on a firm’s quality assurance and bottom-line....

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....

FDA and EMA Finalize Guidances to Help in Postapproval Change Management

FDA and EMA have issued final guidances intended to help industry better understand and manage the regulatory expectations for postapproval CMC changes....
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