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The News in Depth

COVID-19 Vaccine Urgency Throws Spotlight on Next-Gen Sequencing for Virus Control

The urgency of delivering a vaccine for COVID-19 in previously unattainable timeframes and volumes is throwing the spotlight on the expanded role next-generation sequencing (NGS) needs to play to avoid the time delays and other limitations of in vivo/animal testing.

PART II: Sanofi Pasteur and Ghent University Experience with NGS [CLICK HERE]

PART III: A Decade of Regulator/Industry Collaboration on NGS [CLICK HERE]

PART IV: Stakeholder Engagement Begins on ICH Q5A Revision [CLICK HERE]

PART V: Effort to Reduce Animal Testing for Vaccines Includes Global Health Fund Support for NGS
[CLICK HERE]


NIIMBL Progress Includes Partnership with Biophorum on Buffer Mixing and Global Health Fund with Gates Foundation

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is partnering with the industry consortium BioPhorum to develop a more streamlined, cost-effective, and resource-conserving way of addressing the buffers used in biopharmaceutical manufacturing.

IPQ Monthly Update – March 2020 in Review

The first story in the March Monthly Update explores recent FDA global field inspection and enforcement operations. In focus are: ● the impact of the pandemic ● the field office’s API and drug product inventory and enforcement tools ● recent warning letter and import alert data and trends, and ● progress on the goals of reducing the timelines for inspection classification/notification and warning letter issuance. The following story provides insights from FDA’s drug compliance management on the recent global developments and trends of significance across the API, OTC, sterile product, compounding, and supply chain arenas.

Top FDA Drug Compliance Concerns during 2019 Included OTCs, Supply Chain Information Flow, Compounding, and Genotoxic Impurities

Over-the-counter (OTC) drugs – from raw material supply through product manufacturing and distribution – remained a central concern at the FDA Center for Drug Evaluation and Research (CDER) Office of Compliance (OC) during 2019.

Existing Accelerated CMC, Advanced Manufacturing, and Inspection Initiatives are Supporting Regulators in Pandemic Response, FDA’s Cruse Explains in Recent Field Office Updates

Initiatives that the major regulatory agencies have been advancing to help address the CMC and technology challenges of developing complex medicines under accelerated timelines are creating a critical foundation for responding to the current coronavirus pandemic.

IPQ Monthly Update – January/February 2020 in Review

In this issue, IPQ explores the need for excipients that are fit-for-purpose in meeting the complex challenges of formulating, manufacturing, and delivering the new generation of medicines and making them as safe, efficacious, and patient- and distribution-friendly as possible. The five parts of the story focus on: ● a novel excipient review proposal from FDA and stakeholder comments ● industry thought leaders on the novel excipient drivers ● the issues involving subcutaneous biotherapeutics, pediatrics, and delayed release ● USP initiatives supporting novel excipient development, and ● assessing and managing excipient risks.

Attention Heightens on Creating an Independent Regulatory Pathway for Introducing Novel Excipients

IPQ’s five part series is exploring the need for: ● a more qualified-for-purpose excipient toolbox that can help address the formulation, quality, and manufacturing challenges posed by a new generation of medicines, and ● a regulatory process that can better accommodate novel excipients.

INTRODUCTION [CLICK HERE]

PART I: FDA’S Novel Excipient Program Proposal and Stakeholder Comments [CLICK HERE]

PART II: IPEC/IQ Thought Leaders on the Novel Excipient Drivers
[CLICK HERE]


PART III: Subcutaneous Biotherapeutics, Pediatrics, and Delayed Release [CLICK HERE]

PART IV: USP Initiatives Supporting Novel Excipient Development
[CLICK HERE]


PART V: Assessing and Managing Excipient Risks
[CLICK HERE]

IPQ Monthly Update – December 2019 in Review

The December issue explores the collaborative efforts in which industry and regulators are now engaged to address the challenges of assuring the quality and availability of medicines across an increasingly globalized supply chain. The first story reviews various components of the progress that is being made in inspection-related information, standards and resource sharing – with a focus on the US and Europe, in particular – while the second shifts the focus to the Southeast Asia regional efforts going on through ASEAN.

US/EU MRA Implementation, US Congressional Hearings, and Industry Surveys Shed Light on Global GMP Inspection Challenges and Collaboration Opportunities

During the past decade, industry and regulators around the world have been heavily focused on addressing the daunting challenges of assuring the quality of medicines across an increasingly globalized supply chain.

International Mutual Inspection Recognition Expands with ASEAN Accrediting Philippines Using PIC/S Criteria

The FDA Philippines (FDAP) has been approved to join the regulatory agencies of Singapore, Malaysia, Indonesia, and Thailand on the Association of Southeast Asian Nations (ASEAN) Listed Inspection Services (LIS), after an extended review process that included documentary, on-site, and in-process inspection assessment.
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CLICK HERE  for the IPQ Monthly Update – March 2020 in Review


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