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Archive for ‘August, 2010’

Separate Review Track Proposed for Design Space to Avoid Marketing Application Approval Delays

A separate review track for design spaces could allow more room for industry/regulator dialogue on the issues involved without delaying the clearance process for the marketing application, Health Canada Center for the Evaluation of Radiopharma-ceuticals and Biotherapeutics Director Anthony Ridgway suggested at a CMC Strategy Forum on implementing quality by design (QbD) cosponsored by the biotech science society CASSS and FDA in mid-July....
August 30, 2010 | Posted in CMC Review Policy, ICH Q8-10/QbD, International Harmonization, Marketing Application/General, The News in Depth, US/Canada | Read More »

FDA Concern with Particle Contamination and Related Investigations Resurfaces in Warning Letter to Sterile Drug Contract Manufacturer

A mid-August warning letter addressing March inspection findings at contract drug manufacturer Hyaluron highlights FDA’s ongoing concerns with particulate contamination problems and their investigation in aseptic manufacturing. The warning letter was issued to the CEO of New York-based Albany Molecular Research, Inc. (AMRI) which purchased ten-year-old Hyaluron in June after the inspection....
August 26, 2010 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, Injectable, The News in Depth, US/Canada | Read More »

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.
August 25, 2010 | Posted in The News in Depth | Read More »

IPQ Monthly Update — August 2010

Now available, IPQ’s “Monthly Update -- August 2010” on key CMC/GMP developments in the US, Europe, and internationally. The IPQ family of publications has been expanded to include breaking stories “In the News” on our web site, “Weekly News Alerts” sent via e-mail, and the “Monthly Update.”...
August 24, 2010 | Posted in Issue Archive, Monthly Update | Read More »

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....
August 23, 2010 | Posted in CMC Standards, Formulation, The News in Depth, Transdermal, US/Canada | Read More »

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....
August 22, 2010 | Posted in CMC Standards, Formulation, Oral, The News in Depth, US/Canada | Read More »

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....
August 21, 2010 | Posted in Biosimilar, CMC Review Policy, Europe, Marketing Application/General, The News in Depth | Read More »

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....
August 21, 2010 | Posted in Biosimilar, CMC Review Policy, Europe, Generic/Biosimilar, The News in Depth | Read More »

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....
August 20, 2010 | Posted in API, CMC Review Policy, Product Type Specific, The News in Depth, US/Canada | Read More »

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....
August 16, 2010 | Posted in Europe, Medical Gas, Supply Chain/GDPs, The News in Depth, Track and Trace | Read More »
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