IPQ Inside the global regulatory dialogue

The News in Depth

Biopharma Is Working with Analytics Providers and Government Agencies to Further Multi-Attribute Method Use in QC

Biopharmaceutical manufacturers are seeking to expedite the process of taking multi-attribute methodology (MAM) from the development to the quality control (QC) arena and are working with analytics providers and government agencies to help address the challenges involved.

IPQ Monthly Update – April / May 2017 in Review

The issue opens with an in-depth analysis of the array of significant new developments that have occurred in 2017 in FDA’s push to strengthen its regulatory process for drug/device combination products. The focus than shifts to the experience and learnings of the first two companies to cross the CM approval finish line – Vertex and J&J’s Janssen. Moving to developments abroad, the final story centers around the impact on global excipient and pharma filings and product compliance of new requirements in China for the “bundling” of the excipient approval process with drug dossiers.

Janssen Highlights Value of Academic Collaboration in Move to Continuous Manufacturing

Janssen scientists involved in the successful transition from batch to continuous manufacturing (CM) for its anti-HIV product Prezista are forthright in their recognition of the role played by academia – especially Rutgers University – in addressing the technical and regulatory challenges.

Global Excipient and Drug Manufacturers Weigh Implications of China’s New Excipient Dossier and “Bundling Review” Requirements

Global excipient and pharmaceutical manufacturers are weighing the complexities and consequences of the new “bundling review” requirement put in place by the China Food and Drug Administration (CFDA) in August 2016, which calls for excipient dossiers to be received, reviewed and approved as part of new drug applications.

New and Generic Drug User Fees, 21st Century Cures Act, Fuel FDA Regulatory Process and Culture Changes for Combination Products

The process of reauthorizing user fees for new and generic drug products has afforded the Center for Drug Evaluation and Research (CDER) the opportunity to work cooperatively with industry to drive significant cultural and process enhancements in its regulation of drug/biologic/device combination products.

Vertex Sheds Light on Continuous Manufacturing Approval and Post-Approval Challenges

The detection and segregation of non-conforming materials and the justification of sampling plans and locations will be key regulator concerns in reviewing the control system for continuous manufacturing (CM) operations, Vertex is advising based on its experience as the first company to have gone through the CM clearance process at FDA.

IPQ Monthly Update – February / March 2017 in Review

The issue begins with a story on FDA’s broad-based effort to strengthen the governance, process and outreach aspects of its handling of combination products. Also in focus is the intensive dialogue that is happening around continuous manufacturing. Addressed in separate stories are: ● FDA insights from its growing CM experience, and ● the challenges of assuring excipient viability for CM.

Continuous Manufacturing is Driving More Focus on Excipient Fitness for Purpose

The deployment of continuous manufacturing (CM) is prompting the pharmaceutical industry to understand better the characteristics of the excipients they are using and work more closely with suppliers to assure that the materials are fit for purpose. CM is also prompting a harder look at how to open up the clearance pathway for new/modified excipients […]

CDER Offering More Concrete Advice on Continuous Manufacturing as Experience Grows

FDA’s Office of Pharmaceutical Quality (OPQ) has gained enough experience in interacting with industry on implementing continuous manufacturing (CM) operations to be able to offer more concrete advice on the considerations that warrant extra attention.

FDA’s Broad-Based Effort to “Modernize” Combination Product Regulatory Process in Full Swing

FDA’s broad-based effort to “modernize” its regulatory process for products that contain some combination of drugs, biologics and devices gained significant momentum during 2016, and the impact of the effort will continue to increase as 2017 progresses.
Pages: Prev 1 2 3 ...7 8 9 10 11 12 13 ...61 62 63 Next

Subscription Benefits

SUBSCRIBE TODAY and get 24/7 access to the IPQ family of publications:

● “In the News” — breaking stories on our website

● “News Alerts” — sent via email

● “Monthly Updates” — the key CMC and GMP developments in the US, Europe and internationally

● “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern

Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library



CLICK HERE  for the IPQ Monthly Update – June 2020 in Review

IPQ takes its readers from:

● the headlines to the forces driving them

● regulations and policies to their underlying intent

● the pieces of the puzzle to their interconnection

● requirements to implementation pathways

● random data to critical trends

● the sidelines to helping shape the outcome

● compliance problems to proactive quality tools

● information to intelligence


©2020 IPQ Publications