The News In Depth

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.

July 11, 2017 | Posted in The News in Depth | Read More »

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.

July 4, 2017 | Posted in The News in Depth,Uncategorized | Read More »

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.

July 1, 2017 | Posted in The News in Depth,Uncategorized | Read More »

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.

June 19, 2017 | Posted in The News in Depth,Uncategorized | Read More »

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.

May 17, 2017 | Posted in The News in Depth,Uncategorized | Read More »

IPQ Monthly Update – February / March 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.

May 4, 2017 | Posted in The News in Depth | Read More »

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 […]

April 17, 2017 | Posted in The News in Depth,Uncategorized | Read More »

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.

April 12, 2017 | Posted in The News in Depth,Uncategorized | Read More »

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.

March 21, 2017 | Posted in The News in Depth,Uncategorized | Read More »

IPQ Monthly Update – January in Review

During January, IPQ’s attention turned to the potential that international cooperation offers as regulatory agencies move down the pathway from information sharing to mutual recognition. ● The first story focuses on WHO’s role in regulatory capacity building in the biotherapeutics arena. ● The second story provides more on the other key organizations involved in advancing the medicinal quality regulatory process internationally – how they interrelate, what they are trying to accomplish, and the progress they are making.

March 10, 2017 | Posted in The News in Depth | Read More »