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The News in Depth

Expanding Field of Advanced Therapies Puts Pressure on FDA’s Review Staff to Keep Pace

Regulators facing the diversity and complexity of advanced therapies are being challenged with achieving the right balance between providing the regulatory flexibility needed to foster their development and assuring that CMC processes are in place to maximize product safety and avoid the mishaps that could significantly derail their progress.

Facility and Excipient Information Shortfalls Identified by FDA As Among Key Contributors to ANDA Review Delays; GDUFA II Driving Expanded Guidance

FDA’s Office of Generic Drugs (OGD) is cautioning ANDA sponsors to pay more attention to making sure that current information is provided on all of the facilities involved in the development, manufacturing, control testing and warehousing of APIs and finished dosage forms in both the Form 356h and application module 3.2.S.2.

IPQ Monthly Update – December 2017 in Review

During the latter part of 2017, IPQ’s attention returned to the complex CMC challenges that the new, widely-diverse cell and gene therapies (CGTs) are presenting. In this Monthly Update, we share insights that have been offered at recent public forums by leading agency and industry experts on these challenges. [See IPQ’s March 2015 Monthly Update for our last in-depth review of CGT regulatory developments.]

NIST is at Intersection of Industry/Government/Academia Efforts to Support the “Ecosystem” Needed for Cell/Gene Therapy Advancement

The U.S. National Institute of Standards & Technology (NIST) is among the organizations rising up across the industry/government/academia spectrum to support the complex “ecosystem of capabilities” needed to develop, manufacture and deliver cell and gene therapies (CGTs).

Industry/Regulator Communication is Linchpin in Addressing Cell/Gene Therapy CMC Challenges, Experts on Both Sides Are Affirming

Industry and agency experts engaged with advanced therapies are stressing that the communication process between them is critical in clearing the CMC pathway for development of the products and that this communication needs to happen as early and as openly as possible to help sponsors navigate around the many pitfalls that lie along the journey.

IPQ Monthly Update – October / November 2017 in Review

The first two stories in this issue explore the drug GMP compliance concerns that are most pressing on the FDA agenda as 2018 approaches. The third story returns to the intensifying global dialogue on the stresses industry and regulators are feeling as they wrestle with how to advance drug/biologic/device combination products in the context of regulatory structures and processes not very well adapted to handle them.

Faster Inspection Follow-Up, Global Workload, Draw CDER Compliance Office Attention as 2018 Approaches

The impact of FDA’s foreshortened inspection classification timelines, as prescribed by the second installment of the Generic Drug User Fee Act (GDUFA II), will include placing additional weight on the quality of the 15-day inspection responses, agency compliance officials are noting. 

Contracting Relationships and Quality Agreements Are High on FDA’s Inspection Radar Screen

The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) is making clear in its public presentations, compliance actions, and guidance to industry that the relationship between contract manufacturers and product owners – and the quality agreements they have in place to facilitate this relationship – will be a key focal […]

Europe is Assessing Challenges of Implementing Combination Product Regulatory Changes; Attention on CPs Increasing Globally

The stress on the resources and expertise of the European notified bodies in taking on the assessment of the device component of higher-risk drug/device combination products is among the significant challenges the EU faces as it enters the implementation phase of its new medical device and in vitro diagnostic regulations (MDR/IVDR).

IPQ Monthly Update – August / September 2017 in Review

The three stories in this issue provide insights from industry and agency thought leaders on how the pharma imperatives of innovation, acceleration and regulatory harmonization are putting pressure on the existing regulatory processes and quality systems and what industry and agencies such as FDA are doing to try to evolve them.
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