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The News in Depth

CDER’s Office of Pharmaceutical Quality is Opening New Regulatory Pathways to Span Its Broad Responsibilities and Global Reach

The “strategic priorities” of the Office of Pharmaceutical Quality (OPQ) for the next few years speak to the breadth and global reach of its regulatory responsibilities, and to OPQ’s willingness to open new pathways to fulfill them.

Technology Roadmapping Leads NIIMBL Project Expansion Across Biopharmaceutical Manufacturing/Analytics/Workforce Landscape

Technology roadmaps specific to vaccines, gene therapies, and antibody drug conjugates (ADCs)/bispecifics are the first of the many impactful industry/government/academia collaborative projects in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) portfolio to reach completion.

UK MHRA’s “No Deal” Brexit Preparations Include Role for “Responsible Person – Import”

The new role of “Responsible Person – Import” is among the proposals the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has developed through its engagement with stakeholders to prepare for the possibility of an unwanted “no-deal” exit of the UK from the European Union (EU).

Retiring FDA Office of Generic Drugs Director Uhl Cautions Industry that Haste Makes Waste in Application Approval Timelines

In offering some of the key learnings from her tenure as Director of FDA’s Office of Generic Drugs, Kathleen “Cook” Uhl is stressing that a “slow” and careful approach by sponsors during the ANDA submission and review process will actually result in faster approvals.

IPQ Monthly Update – November 2018 in Review

The November Update provides a four-part report exploring the increasing challenges that industry and regulators around the world are now facing from climatic, demographic, political, and economic disruptions, and how they are being addressed. The four parts focus on: ● pharma company investment in disaster preparation ● FDA’s emergency response efforts ● the mega-trends putting supply chains at risk, and ● a panel discussion on Hurricane Maria’s impact.

Emergency Preparations Draw Heightened Industry and Regulator Attention as Natural and Man-Made Disasters Proliferate

Extreme weather events, political instability, and economic disruptions are prompting the pharmaceutical community to heighten its focus on emergency preparedness. The following four-part report focuses on conference presentations and discussions during 2018 that have made a significant contribution to understanding the increasing challenges that industry and regulators are now facing around the world and how they […]

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.

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.

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.

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).
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