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CDER Officials Shed Light on Forces Impacting Generic Injectable GMP Compliance and Drug Shortages

FDA’s current engagement with the GMP compliance problems in the generic injectable arena illustrates the tightrope the agency is walking in trying to protect patients against substandard, high-risk products, while at the same time trying to assure that they have access to the critical medicines they need...

Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility – focusing more heavily on identifying and monitoring critical process steps than on reviewing batch records....

Ben Venue Consent Decree Traces History of Injectable GMP Noncompliance and Defines Remediation Pathway

FDA findings at Ben Venue’s Bedford, Ohio injectable manufacturing facility in 2011 that GMP problems cited in a 2007 warning letter had still not been corrected resulted in a consent decree, approved by the US District Court of Northern Ohio on January 31....

FDA’s Draft ANDA Stability Guidance Applies ICH Expectations to Generics

The Office of Generic Drugs (OGD) has released a new draft guidance indicating that Abbreviated New Drug Applications (ANDAs) and the Drug Master Files (DMFs) that support them will be expected to follow the stability recommendations provided in the ICH Q1A-E stability guidelines....

The Monthly Update for September is Now Available

The September Monthly Update takes a deep dive into FDA’s broad-ranging efforts to create a more efficient and effective generic drug review process, supported by QbD and user fees, that can address an expanded backlog of ANDAs and fulfill its GUDFA commitments to industry....

New OGD Director Geba May Take the Helm of a Super Office; CDER Director Woodcock Sharpening Center’s Quality Focus

The new director of the Office of Generic Drugs (OGD) will likely take the helm of a new FDA “super office,” being proposed to reflect the heightened focus on generic drug regulation and the challenges posed by an increasing number of applications and the passage of the Generic Drug User Fee Amendments (GDUFA)....

GPhA Weighs In On API and QbD Issues Needing Clarification for Generics; OGD Outlines Starting Material Expectations

The designation of drug substance starting materials and the information that will need to be provided on them in Drug Master Files are among the issues on which members of the Generic Pharmaceutical Association (GPhA) are asking for further clarification from FDA’s generics office as it moves forward in upgrading its review processes with the support of quality-by-design (QbD) principles and user fee resourcing....

New FDA ANDA Stability Guidance Will Embody ICH Standards; GPhA Supportive With Some Adjustments

The Office of Generic Drugs will be issuing a new draft stability guideline that will more formally align the expectations for Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) with ICH and a QbD-oriented regulatory paradigm....

GDUFA Expectations for Fee Payment and Facility Registration Out for Comment; Public Meeting Scheduled

FDA has put on the table its expectations for complying with the Generic Drug User Fee Amendments (GDUFA) – including two draft guidances clarifying the payment of fees and registration of manufacturing facilities – and is asking for quick industry feedback as the beginning of the implementation process for GDUFA draws near....

Initiatives to Strengthen FDA’s Generic Drug Review Process Include OGD Supplement and Peptide Teams

FDA’s Office of Generic Drugs (OGD) has created dedicated teams for the review of supplements and peptide drugs as part of an office-wide effort to improve the efficiency and effectiveness of its review processes and explore where policy and resource improvements are needed....
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