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IPQ’s August “Monthly Update” on Key CMC/GMP Developments in the US, Europe, and Internationally is Now Available

Included in the US coverage in IPQ’s just-released “Monthly Update -- August 2010” is advice from FDA biotechnology regulators on how to communicate with the agency to avoid CMC stumbling blocks and smooth the development, IND and marketing application clearance process for new biotech products. On the inspection side, in focus are: ● Congressional efforts to upgrade FDA’s recall and supply chain authorities ● the latest on McNeil’s compliance issues and the impact on J&J finances ● the new inspection initiative by CDER putting Part 11 back in the limelight, and ● a warning letter to Sanofi that shows FDA’s ongoing concern with vaccine manufacturing.

FDA Draft Guidance Promotes the Use of QbD to Help Solve Residual Drug Problems in Transdermal Delivery Systems

FDA’s new draft guidance on transdermal and related drug delivery systems discusses the agency’s concerns with the residual drug left in the delivery systems after the intended use period and recommends manufacturers use quality-by-design (QbD) principles to minimize the problem for both new and existing products....

New Oral Formulation Approaches Are Accelerating Product Movement Into the Clinic

The use of micro-dosing in clinical formulations is increasing as firms wrestle with how to get their new oral drug products to the clinic as quickly as possible with the fewest regulatory hurdles....

Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says

The biopharmaceutical regulatory challenges confronting the EMA over the next decade – from biosimilars, advanced therapies, personalized medicine and transgenics to variations and quality by design – will require close industry/regulator dialogue and new communication channels, recently retired EMA Quality of Medicines Head John Purves stressed at CASSS’ European CMC Strategy Forum in Vienna in late May....

Biosimilar Products, Guidelines and Requests for Scientific Advice Continue to Increase in EU

The European Medicines Agency (EMA) portfolio of approved biosimilar products and guidelines and the related requests for scientific advice continue to expand, with interest increasing in particular in monoclonal antibodies....

FDA Releases Guideline on Animal Drug Substance CMC Filings in CTD Format

FDA’s Center for Veterinary Medicine (CVM) has released a guideline on how to file drug substance CMC information for new and abbreviated new animal drug applications (NADAs/ANADAs) in the Common Technical Document (CTD) format. The CMC guideline was released as a final version rather than as a draft for comment....

EMA Issues Q&A on Supply Chain Traceability to Support Revised Medicinal Gas Annex

EMA recently issued a Q&A addressing supply chain traceability expectations for medicinal gases to support the revision to Annex 6 to the EU GMP Guide. The revised annex on “The Manufacture of Medicinal Gases” was adopted by the European Commission at the end of January and became effective at the beginning of August....

The August Issue of IPQ’s New “Monthly Update” Coming Soon

Don’t miss IPQ’s “Monthly Update – August 2010” due out later this week. IPQ’s new “Monthly Update” publication covers the key GMP and CMC developments in the US, Europe, and internationally....

India Strengthening its Central Regulatory Authority to Keep Pace with Industry Expansion

India is working to strengthen its central drug regulatory authority and related laws and regulations in response to its rapidly expanding domestic industry and the need for more interaction with foreign regulatory counterparts....

FDA/EMA Joint Inspection Program for Finished Products Seeking Applicants

The EMA is continuing to seek drug manufacturers willing to participate in its joint inspection program with FDA for finished products. In an August 11 announcement, EMA explained that companies that have submitted two equivalent applications for the same product to both EMA and FDA can request to participate in the pilot....
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