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IPQ Monthly Update – March/April 2018 in Review

Industry and regulators in the US and Europe are making a concerted effort to improve the depth and clarity of their communications on the manufacturing and control of drug/biologic/device combination products. The three stories in this issue explore the challenges of melding the drug and device regulatory worlds and what is being done to address them.

Understanding Drug/Device Terminology Differences is Critical to Combination Product Control and Regulatory Communications, Industry Experts are Stressing

Industry experts are stressing that the payoff for combination products in understanding and bridging the drug/biologic/device terminology differences is a smoother development process, a simpler, more effective control system, and better communications with CMC reviewers and GMP inspectors.

FDA Inspection Findings Provide Additional Insight on CGMP Expectations for Combination Product Manufacturers

The light being shed on the current GMP regulatory expectations for risk management and manufacturing control of combination products by FDA’s inspection engagement with pharma sponsors and their device partners has been a focal point at recent conferences in the US and Europe.

Improving Communications on Drug/Device Combination Product Quality and Performance is an Increasing Priority in the US and Europe

Industry and regulators in the US and Europe are wrestling with how best to interpret and communicate drug quality-by-design (QbD) concepts, device design controls (DC) and overall final product risk management in the drug/biologic/device combination product context. 

IPQ Monthly Update – January/February 2018 in Review

During January and February, IPQ was focused heavily on the emerging challenges faced by regulators due to the rapidly increasing number of applications encompassing new products and therapies, technologies and processes. The three stories in this issue explore: ● how FDA’s generic drug review process is evolving with user fee support to address the increasing number and complexity of products emerging through it ● how CBER is responding to the wave of advanced therapies it is now facing, and ● a CDER/CBER view of the current biologic product CMC review landscape and the BLA challenges, accomplishments, and learnings.

Opening Panel at CASSS 2018 WCBP Conference Assesses FDA’s 2017 CMC Regulatory Experience with Biotherapeutics and Key Challenges Going Forward

The opening plenary session of the 2018 CASSS Well-Characterized Biotechnology Products (WCBP) Conference, brought together a panel of FDA senior officials engaged in the CMC review process for biological products to assess the 2017 learnings and what the agency and industry needs to do to address the regulatory challenges and stresses going forward.

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).
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CLICK HERE for the IPQ Monthly Update – March/April 2018 in Review



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