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The News in Depth

CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs

As its experience grows with reviewing cell and gene therapy (CGT) processes, equipment and facilities, CBER is strongly recommending that firms start early in thinking about the engineering and capacity needs of a commercial facility.

IPQ Monthly Update – August 2019 in Review

The three stories in the Monthly Update for August explore facets of the intense discussions that are now taking place at industry/regulator forums on the CMC challenges that need to be faced en route to realizing the promise of cell and gene therapies. In focus are: ● the dialogue at the NIIMBL annual meeting on these challenges and the industry/agency/academia collaboration needed to meet them, and ● an exploration by CBER and industry experts on the added CMC pressures created for CGTs by accelerated development and review timelines and how these pressures can be dealt with.

Preparing for CMC Changes is Difficult but Pivotal to Accelerating CGT Development, Industry Experts Are Stressing

Cell and gene therapy (CGT) sponsors are wrestling hard with how to prepare for having to make CMC changes throughout the development, submission, and post-approval stages, while facing accelerated timeframes and significant knowledge limitations.

CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies

Reviewers with FDA’s Center for Biologics Evaluation and Research (CBER) are working with sponsors to determine how and where flexibility can be applied in the type and extent of CMC information expected at the time of cell and gene therapy (CGT) product submissions.

CBER and CDER Directors Offer Insights on Overcoming Hurdles to Biomanufacturing Innovation at NIIMBL Annual Meeting

Among the ways that public/private collaborations could play a critical role in advancing cell and gene therapy (CGT) manufacturing would be helping create a non-proprietary set of adeno-associated virus (AAV) vectors, CBER Director Peter Marks proposed at the third annual meeting of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), held in Crystal City, […]

IPQ Monthly Update – July 2019 in Review

The first story in IPQ’s Monthly Update for July explores the FDA/CDER efforts to make its quality review process more standardized, transparent, streamlined, IT rich, and knowledge management friendly through its interrelated KASA and PQ/CMC initiatives. The second story explores the attention industry and regulators are now giving to the complex web of issues that come into play in the effective use of preservatives in pharmaceuticals.

Regulators and Industry Are Probing More Deeply into the Complexities of Preservative Usage

Regulators and industry are exploring more deeply the complex web of issues involved with effective use of preservatives in drug products, as the challenges and the consequences come into clearer view.

KASA and PQ/CMC Initiatives Gain Momentum in FDA’s Effort to Strengthen Quality Review Process

The efforts of FDA’s Office of Pharmaceutical Quality (OPQ) to standardize and streamline the CMC information in applications and how it is reviewed – initially for abbreviated new drug applications (ANDAs), and eventually for NDAs, and even biological license applications (BLAs) – is beginning to take concrete form.

IPQ Monthly Update – June 2019 in Review

The first story in IPQ’s June issue provides an update on the effort going on in Europe to create a more transparent, effective, and uniform process for regulating the quality of drug-device combination (DDC) products and how a draft guideline issued in June is contributing to that effort. The second explores the regulatory developments in China, the implications for pharma and excipient suppliers producing products for a global market, and how IPEC is encouraging China to more closely align with international norms.

EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment

EMA’s draft guideline on quality requirements for drug-device combination (DDC) products provides a template for the new concept of the notified body opinion (NBOp), intended to help ensure a consistent interpretation by individual assessors, notified bodies, and industry.
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