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Better Human Factors Analysis is Driving New Combination Product Technologies Designed to Reduce User Errors

Multi-sensory training tools and design features for auto-injectors, including audio instructions, are among the error-reduction technologies being driven by better human factors (HF) analysis in the drug/device combination product arena....

ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership

Singapore is leading an effort by the Association of Southeast Asian Nations (ASEAN) to achieve a harmonized approach to process validation modeled on FDA’s lifecycle approach and the ICH Q8-10 paradigm it embodies....

FDA Releases Final Guidance on PET Drug INDs

FDA has released a final guidance on Investigational New Drug (IND) Applications for Positron Emission Tomography (PET) Drugs that updates a draft released in February with only minor changes. The guidance summarizes the IND process for unapproved PET drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, […]

EMA Process Validation Draft Targets Filing Requirements and Assessor Needs

The European Medicines Agency (EMA) has released a draft process validation (PV) guideline that mirrors FDA’s PV guide in principle, but is aimed more at the content and assessment of marketing authorization applications rather than the execution of validation in a manufacturing facility....

EMA Invites Registrations for eSubmission Gateway

The European Medicines Agency (EMA) is inviting pharmaceutical companies to register to take part in a three-month pilot of its “eSubmission Gateway” beginning on January 9, 2012. The eSubmission Gateway is a new electronic submission channel that applicants will be able to use to submit applications for centralized marketing authorizations for human medicines in the […]

FDA’s ONDQA Bolsters its QbD Review Effectiveness

FDA is continuing to refine its quality-by-design (QbD ) review framework by creating QbD “CMC lead” and “liaison” positions within the Office of New Drug Quality Assessment (ONDQA), instituting an internal database of QbD application elements for use by reviewers, and increasing collaborative research between ONDQA and academia on QbD-focused topics....

European Commission Clarifies Position on Duplicate MAAs

The European Commission has published its position on the “handling of duplicate marketing authorization applications (MAAs),” explaining the circumstances in which duplicate MAAs can be submitted for the same product.  The document notes that duplicates are on the increase “as the use of the centralized procedure rises.” In general, only one MAA can be granted […]

Current Staffing Levels at China’s SFDA May Hinder QbD Submissions; Investigational-Stage Changes and Timelines Also at Issue

International pharma is expressing concern that the ability to put ICH Q8-10 principles into practice in China is hampered by the significant limitations in its current review manpower....

EMA Plans Revisions to Influenza Vaccine Guidance

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Health Canada Announces Increased Scope of Submissions Being Accepted in eCTD Electronic-Only Filing Format

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