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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.

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.

IPQ Monthly Update – November 2019 in Review

In this issue, IPQ explores the prominent FDA and industry association initiatives that are active in the quality metrics and culture arena – how they are progressing, how they interrelate, their impact, and the learnings they are providing. The first story focuses on the initiatives taking place on the pharma side, while the second shifts to the implementation of the Center for Devices' highly relevant Case for Quality and voluntary improvement pilot programs.

CDRH Case for Quality Voluntary Improvement Pilot Collaboration Shows Impressive Results for Device Manufacturers

FDA’s Center for Devices and Radiological Health (CDRH) expects to fully implement its “Voluntary Manufacturing and Product Quality” program in 2020, following a positive experience during the pilot phase of this highly collaborative alternative to traditional agency inspections.

FDA and Industry Quality Metrics Initiatives Are Paving for Way to Manufacturing and Regulatory Advancements

Three FDA quality metrics initiatives – involving site visits, industry feedback, and academic research – are expanding the understanding of how metrics can be most effective in advancing pharmaceutical quality and culture and preventing process failures and product shortages, while streamlining regulatory oversight.
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