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The Role of QbD in ANDA Review Draws Comment from Generics Office Management

FDA’s Office of Generic Drugs (OGD) is advising industry that consistency around key quality-by-design (QbD) terminology will help release the potential of QbD to facilitate the Abbreviated New Drug Application (ANDA) review process....

EMA’s Biosimilar Quality Guideline Redraft Sharpens Focus on Target Profiles and Lifecycle Changes of Reference Product

The new draft of EMA’s biosimilars quality guideline includes a heightened focus on understanding the quality target product profile (QTPP) of the reference product and the changes that have occurred to the quality attributes over the reference product’s lifecycle....

Vertex Harnesses QbD to Solve Difficult Formulation and Manufacturing Issues

Vertex’ experience with the development and approval of its oral solid hepatitis-C drug Incivek (telaprevir) testifies to the power of quality by design (QbD) to solve the problems posed by molecules that are difficult to develop, formulate and manufacture....

Biopharm Modeling and Continuous Manufacturing Will Help Drive Vertex’ Drug Development and QbD

Vertex is focusing on biopharmaceutics modeling and continuous manufacturing as potentially powerful tools for advancing its drug development and quality by design (QbD) program....

Analysis of Post-Change Comparability and PEGylation Among Biotech CMC Concerns Drawing FDA Comment at AAPS National Biotech Conference

The expectations for pre- and post-change lot comparisons and for PEGylation analysis were among FDA CMC application filing concerns addressed by CDER Office of Biotechnology Products (OBP) official Susan Kirschner at an “ask the regulator” session at AAPS’ National Biotech Conference in late May in San Diego, California....

EMA’s Biotech CMC Focal Points Include Biosimilar Guideline Revisions and Joint Reviews with FDA

EMA is nearing release of revised drafts of its biosimilars guidelines to reflect experience gained and stakeholder input and is refining its cooperative application review process with FDA – two of the European agency’s focal points in the biotech CMC arena....

EMA’s Finalized Biological IMP Quality Guideline Furthers European Clinical and Biotech Review Harmonization

EMA’s finalized guideline on “the requirements for quality documentation concerning biological investigational medicinal products in clinical trials” reflects significant changes made to the draft resulting from extensive industry/regulator dialogue and marks an important step in the agency’s efforts to harmonize requirements in the clinical and biotech arenas across Europe....

Uptick in Data Integrity Problems Leads FDA to Better Define Types and Red Flags

Un uptick in the number of data integrity problems that FDA is finding at manufacturing and testing facilities is prompting the drug compliance office to better define the forms in which the integrity problems can appear and the red flags that will trigger more intensive investigations....

FDA Releases Final Guidance on PET Drug Media Fills; Application Filing Deadline Extended

FDA has finalized a guidance on positron emission tomography (PET) drug media fills that was released as a draft last September and has effectively extended the December 2011 deadline for PET drug application submissions until June....

EDQM’s Efforts to Clarify Starting Material Expectations Include Internal Policy Guide; SM Dialogue Continues

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has been working hard to better define its policies around starting materials in view of their impact on the regulation of active pharmaceutical ingredients (APIs)....
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