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FDA Investigators Will Focus on Simple GMP Lapses when Inspecting Complex Biotech Systems, Former Compliance Official Cosgrove is Advising

Former FDA Center for Drug Evaluation and Research (CDER) senior compliance official Tom Cosgrove, now a partner at the law firm Covington & Burling, is cautioning biotech companies to make sure they are in compliance with the more mundane GMP details, on which investigators will be focused, to keep the regulatory pathway clear for their […]

IPQ Monthly Update – December 2018 in Review

The December issue provides updates on FDA/CDER’s Office of Generics Drugs and Office of Pharmaceutical Quality – what have been the key areas of focus over the past year and what the top priorities are going forward. The third story crosses the Atlantic to explore how Brexit is impacting the MHRA in the medicines arena and what the agency is doing to prepare for what may happen.

Gates Foundation’s Expanded Commitment to Global Medicines Encompasses CMC/Regulatory Problem Solving

The Bill & Melinda Gates Foundation is stepping up its commitment to helping solve the complex chemistry, manufacturing and control (CMC), regulatory, financial, and distribution challenges of providing quality medicines for developing countries.

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.
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