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EMA to Share Generics Assessments

EMA announced in mid-January that it would share its assessments of applications for generic drugs with other regulatory agencies. The first phase of its “International Generic Drug Regulators Pilot,” started in July 2014, involves the EU, Australia, Canada, Chinese Taipei, and Switzerland. Initially ten applications for generics will be shared.

FDA’s Center for Veterinary Medicine Using QbR and Other CDER-Tested Approaches to Decrease Review Times; CVM User Fees Drive Guidance Development

The use by FDA’s Center for Veterinary Medicine (CVM) of a question-based review (QbR) approach in CMC submissions over the past three years has resulted in significantly decreased review times for both new and abbreviated new animal drug applications (NADAs and ANADAs) for multiple dosage forms, including sterile products – in many cases with the reviews accomplished in a single cycle....

FDA Field Operation 2015 Priorities Include Alignment with Centers and Lab Optimization

Top priorities for FDA’s Office of Regulatory Affairs (ORA) in 2015 include closer functional alignment with the agency’s reviewing centers and a major restructuring and optimization of its laboratory operations....

New FDA Biotech Inspection Program Will Mine Ten Years of Industry Data to Enhance Targeting and Execution; Field Refining Risk Ranking Process Across Pharma Spectrum

The Center for Drug Evaluation and Research (CDER) is working to update its biotech inspection compliance program to make better use of the process, product, and compliance information it has collected from the industry in the decade since the previous version went into effect and better target its inspection efforts....

India Unifying Pharmaceutical Departments

According to the Economic Times of India, the Indian government is planning on bringing all of the government groups that deal with pharmaceuticals under one department. Currently there are numerous separate departments that deal with individual aspects of drugs, such as patenting and licensing. The new department would work to create a more cohesive view […]

CDER’s Office of Surveillance Will Oversee Expanding FDA’s QA Assessment Capabilities and Reshaping Inspections

The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility....

Japan and Korea Invited to Join PIC/S

The PIC/S Committee, following a meeting in Rome in mid-May, invited the health agencies of Japan (PMDA) and Korea (MFDS) to join PIC/S at the beginning of July as the 45th and 46th members. Both Japan and Korea had applied for membership in 2012. Applications from the health agencies of Brazil, Hong Kong, Iran, the […]

Injunction Against Laclede For Sale of Unapproved Drugs

An injunction was filed in late June against California-based Laclede for distributing unapproved/misbranded drugs.

FDA 2014-2018 Strategic Priorities

FDA released a draft of Strategic Priorities for Fiscal Year 2014-2018 for public comment at the beginning of July. Five cross-cutting strategies and four mission goals are identified. The five strategic priorities are: ● regulatory science ● globalization ● safety and quality ● smart regulation, and ● stewardship. The core mission goals are to: ● […]

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....
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