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FDA/EMA QbD Parallel Assessment Q&A

In mid-December, FDA and EMA began publishing a series of joint question-and-answer documents that outline the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application. The first one covers the level of detail expected in a QbD submission. FDA and EMA will publish additional question-and-answer documents on other QbD-related […]

CDER MAPP for Chemistry Review of QbR Submissions

A Manual of Policy and Procedures (MAPP) for Chemistry Review of Question-based Review (QbR) Submissions was released in mid-November. The MAPP clarifies how reviewers in OPS should assess NDAs and ANDAs that follow a QbR format. The document lists the benefits that come from using a QbR approach, and in the appendix, the 62 questions […]

Guides on FDA’s Generic Drug Review Process Continue Apace in July; EU Pilot Pursues Generic Drug Review Streamlining Internationally

The efforts by the Office of Generic Drugs (OGD) to clarify and streamline the Abbreviated New Drug Application (ANDA) process and facilitate the implementation of the Generic Drug User Fee Act (GDUFA) continued apace in mid-July with the release of draft guidances on post-approval supplements and easily correctable deficiencies. Comments on the drafts are due by mid-September....

FDA and EMA Extend QbD Pilot, Plan More QbD Guidance

In early March, FDA and EMA announced a two year extension of their pilot program for collaborative review of QbD applications launched in 2011. FDA and EMA also indicated that additional QbD guidances are expected to be published in 2014. [See IPQ March 27 2014 for more on EMA’s 2014 quality initiatives.]

Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum

Industry associations have been meeting with Japanese regulators to highlight the problems they are experiencing in Japan’s process for regulating post-approval manufacturing changes, including a lack of flexibility around biotech product changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations....

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....

ICH Q10’s Role as Guidepost on Pharma Journey from “Blind Compliance” to Operational Excellence Affirmed at PDA/FDA Workshop

ICH Q10 is serving as an important guidepost on pharma’s journey from “blind compliance” to operational excellence, NSF-DBA Senior Partner Neil Wilkinson affirmed in his opening presentation at a PDA/FDA workshop in mid-September....

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....

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....
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