The News In Depth

IPQ Monthly Update – September/October 2018 in Review

The first two stories in the September/October issue offer a wealth of insights from the compliance staff at FDA’s centers for drugs and biologics on their respective front-burner concerns and the actions they are taking. Both the CDER and CBER reviews include the office management perspective as well as what the compliance problems look like at the GMP facility inspection level. The third story shifts focus onto the learnings CDER’s Office of Biotechnology Products (OBP) has garnered from reviewing its BLA experience over the past two decades about how analytics and the regulatory expectations for them have evolved.

December 4, 2018 | Posted in The News in Depth | Read More »

CBER’s Compliance Office Absorbing Impact of Cell/Gene Therapy Wave in its Pre-Market and Surveillance Operations

The high demands that the review staff is facing at FDA’s Center for Biologics Evaluation and Research from industry’s rapidly expanding engagement with cell and gene therapies (CGTs) is also being felt at CBER’s compliance office on both the pre-market and surveillance side of its operations.

November 20, 2018 | Posted in The News in Depth | Read More »

FDA’s BLA Review Sheds Light on Evolution of Biotherapeutic Product Analytical Methods and Their Regulation

Research by FDA’s Office of Biotechnology Products (OBP) into its database and experience with biological license application (BLA) reviews is revealing a lot about the evolving landscape of biotherapeutic product analytical methods and regulatory expectations.

November 12, 2018 | Posted in The News in Depth | Read More »

Foreign Inventory Completion, Faster Inspection Follow-up Among CDER Compliance Office 2018 Achievements; API, OTC Process Findings Spotlighted

The Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) is reporting that during FY 2018 FDA nearly completed the inspections of its foreign manufacturing inventory – a full year earlier than agreed to with the General Accounting Office (GAO).

October 22, 2018 | Posted in The News in Depth | Read More »

IPQ Monthly Update – July/August 2018 in Review

The July/August issue begins with an exploration of how the ICH process has been evolving and the challenges and opportunities that are now presenting themselves. The second story then takes a deep dive into the intensive dialogue taking place on implementing ICH Q12 and its established conditions provisions, in particular. A series of three stories follows on the problems created by the different excipient regulatory frameworks and requirements around the world for both suppliers and users in their efforts to assure and improve the quality and availability of medicines.

October 1, 2018 | Posted in The News in Depth | Read More »

Refined Training, Project Selection, and Membership Processes Strengthen ICH’s Global Harmonization Efforts

Refined processes for training, project selection and membership are strengthening ICH’s ability to realize in practice the global harmonization objectives of its guideline development efforts, ICH leaders are affirming.

September 6, 2018 | Posted in The News in Depth,Uncategorized | Read More »

IPEC Digesting Implications of China’s Ending of Separate Excipient Approval Process

The International Pharmaceutical Excipients Council (IPEC) is working with its members and China’s Center for Drug Evaluation [CDE] to digest and manage the implications of the decision in China to switch from a separate approval process for pharmaceutical excipients to submission and review of an excipient dossier together with a drug application.

August 31, 2018 | Posted in The News in Depth,Uncategorized | Read More »

Diverging Regional Excipient Regulations Are Creating Problems for Excipient Manufacture, Distribution and Use Globally

A review of the way excipients are regulated by agencies around the world reveals that regional regulations continue to proliferate and the differences are creating problems for the manufacture, distribution and use of excipients globally.

August 30, 2018 | Posted in The News in Depth,Uncategorized | Read More »

Novel Excipients, DMFs, and Atypical Actives Among Pressing Issues on IPEC-Americas’ Front Burner

Novel excipients, drug master files (DMFs), and atypical actives are among the pressing issues on which the International Pharmaceutical Excipients Council (IPEC) is actively engaged with the major regulatory agencies and standards organizations around the world.

August 29, 2018 | Posted in The News in Depth,Uncategorized | Read More »

Role of Established Conditions Drawing Attention in Global Dialogue on ICH Q12’S Potential

The interpretation and application of the approaches for determining established conditions (ECs) provided in the Step 2 draft of ICH Q12 and how these interface with regulatory reporting expectations is drawing particular attention as industry explores the opportunities that the ICH Q12 concepts present in practice.

August 13, 2018 | Posted in The News in Depth,Uncategorized | Read More »