Latest Improvements in FDA’s Inactive Ingredient Database Include Change Log and Use of Maximum Daily Exposure
February 9, 2021
FDA’s latest efforts to improve the functionality of its Inactive Ingredient Database (IID) include a quarterly log to track changes in the records and the use of the term “maximum daily exposure” (MDE) in lieu of “maximum potency.”
Recent Technology and Partnership Advances Made Possible Precision and Speed of Vaccine Response to Pandemic, NIAID’s Graham Stresses at CASSS WCBP Conference
February 2, 2021
The precision and speed of COVID-19 vaccine development was made possible by recent R&D advancements and a strengthened network of public-private partnerships, NIH National Institute for Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VCR) Deputy Director Barney Graham affirmed in his keynote presentation at the opening session of the CASSS Well-Characterized Biotechnology Products (WCBP) conference in late January.
Pandemic Intensifies USP’s Focus on Supply Chain Vulnerabilities and Vaccine Development
January 28, 2021
Improving understanding of supply chain vulnerabilities and providing support for vaccine development and delivery are two focal points of the USP effort to help address the pressing challenges that the COVID-19 pandemic has brought to the fore regarding the availability of quality medicines.
Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels
December 23, 2020
The pandemic is prompting all of those involved in medicine production, regulation, and standards-setting to take a hard look at their operations for how they can be: ● adapted to continue being productive and address the pandemic exigencies, as well as ● potentially improved on a longer-term basis. It is also significantly deepening communication and cooperation channels.

Part I: EDQM Pandemic Actions Continue Apace in Fall 2020

Part II: Pharmacopeia, Regulator and Industry Expert Panel Explores Pandemic and Nitrosamine Communications

Part III: Second Panel Focuses on Pandemic Organizational Impacts and Key Learnings

Part IV: EDQM and Ph. Eur. Evolution Addressed by Leaders Keitel and Vielle
COVID Vaccine Global Distribution Challenges Explored by Bio Supply Management Alliance (BSMA) Panel of European Experts
December 3, 2020
A panel of leading experts, assembled virtually for the 2020 Bio Supply Management Alliance (BSMA) Europe symposium on November 12, seized on the analogy of a Formula One race pitstop in assessing the expertise, cooperation, and timing that will be needed for successfully delivering COVID-19 vaccinations.
Pandemic Stresses Increase FDA Attention on Risk Management Plans for Drug Shortage Prevention and Mitigation
November 15, 2020
The stresses of the COVID pandemic on the drug supply chain have thrown a spotlight on the importance of risk management plans (RMPs) in preventing and addressing drug shortages.
USP’s Global Efforts to Strengthen Standards and Accelerate Innovation for Biologics Include ICH Engagement
November 9, 2020
Direct engagement in the ICH guideline development and revision process is helping USP prioritize its related compendial standard setting, revision, and harmonization efforts, and, in turn, enriching ICH awareness of the pharmacopeial standards and approaches that can help inform its guidelines.
CBER Director Marks Traverses the Complex COVID-19 Vaccine/Therapy Regulatory Landscape at FDLI’s Annual Conference
October 13, 2020
At the 2020 annual conference of the Washington, D.C.-based Food and Drug Law Institute (FDLI), held virtually on October 6-8, Center for Biologics Evaluation and Research (CBER) Director Peter Marks provided valuable insights on the difficult terrain that the regulators at CBER have to navigate to reach their goal of making effective vaccines and therapeutics for COVID-19 available as efficiently as possible.
Stronger Unapproved Stem-Cell Enforcement Accompanies FDA Center for Biologics’ Cell and Gene Therapy Advancement Efforts
September 14, 2020
Over the last few years, FDA has ramped up its efforts to protect the public from unapproved and potentially dangerous stem cell products, while striving to create a regulatory framework and approach that is as supportive as possible for the advancement of the entire cell and gene therapy (CGT) field.
Design-Based Development Paradigm for Cell/Gene Therapies Will Significantly Reduce Costs, Timelines and Regulatory Concerns, AGT CEO Galvin Maintains
August 27, 2020
The more efficient, design-based development paradigm for cell and gene therapies, coupled with their therapeutic power, will dramatically reduce manufacturing and testing costs and timelines and significantly alter the regulatory dynamics, American Gene Technologies CEO Jeff Galvin affirmed in his plenary presentation at the PDA annual meeting held virtually in late July.
Synthesis and Analysis Advancements Are Unleashing the Potential of Peptides and Oligos, Spurring CMC Regulatory Dialogue
July 23, 2020
Advancements in synthesis and analysis technologies are helping unleash the therapeutic potential of peptides and oligonucleotides, spurring the dialogue on how the CMC/quality regulatory expectations, guidance and standards should keep pace.
USP Convention Meets Virtually in May 2020 to Review Upcoming Priorities, with Both 200-Year Legacy and Current Pandemic in Focus
July 16, 2020
In May 2020, the USP Convention (USPC) met virtually to review how its central role in advancing public health has evolved during the broad sweep of its 200-year history on the one hand, while assessing its response to the pressing needs of the COVID-19 crisis now dominating the healthcare field on the other.
COVID-19 Vaccine Urgency Throws Spotlight on Next-Gen Sequencing as Key Facilitator
May 31, 2020
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
May 15, 2020
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.
Top FDA Drug Compliance Concerns during 2019 Included OTCs, Supply Chain Information Flow, Compounding, and Genotoxic Impurities
April 16, 2020
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
April 7, 2020
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.
Attention Heightens on Creating an Independent Regulatory Pathway for Introducing Novel Excipients
March 20, 2020
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

PART I: FDA’S Novel Excipient Program Proposal and Stakeholder Comments

PART II: IPEC/IQ Thought Leaders on the Novel Excipient Drivers

PART III: Subcutaneous Biotherapeutics, Pediatrics, and Delayed Release

PART IV: USP Initiatives Supporting Novel Excipient Development

PART V: Assessing and Managing Excipient Risks
US/EU MRA Implementation, US Congressional Hearings, and Industry Surveys Shed Light on Global GMP Inspection Challenges and Collaboration Opportunities
January 15, 2020
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
December 29, 2019
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.
CDRH Case for Quality Voluntary Improvement Pilot Collaboration Shows Impressive Results for Device Manufacturers
December 19, 2019
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 the Way to Manufacturing and Regulatory Advancements
December 12, 2019
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.
Industry Experience with Autologous Cell Therapies Underscores Need for Upfront Planning on Integrating Facility Design, Operations, and Supply Lines
November 8, 2019
Industry experience with autologous cell therapies is matching up with that of regulators in underscoring the importance of comprehensive integrated planning – encompassing internal operations and facility design as well as the complexities of the supply chain – to be able to meet future capacity needs.
The Processing and Formulation Complexities of Therapeutic Biologics Compel Heightened Focus on Excipient Needs
November 5, 2019
The processing and formulation complexities of the new generation of therapeutic biologics are compelling industry and regulators to take a hard look at the risks and requirements of the raw materials and excipients involved.
USP Views Early Broad Stakeholder Engagement as Essential in Developing Performance-Based Standards for Biologics
October 27, 2019
The U.S. Pharmacopeia (USP) views expanded early engagement with key stakeholders through workshops, roundtable meetings/studies, and Pharmacopeial Forum (PF) Stimuli articles as an essential component in advancing performance-based standards for biologic products.
CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs
October 11, 2019
As its experience grows with reviewing cell and gene therapy (CGT) processes, equipment and facilities, CBER is strongly recommending that firms start early in thinking about the engineering and capacity needs of a commercial facility.
Preparing for CMC Changes is Difficult but Pivotal to Accelerating CGT Development, Industry Experts Are Stressing
October 2, 2019
Cell and gene therapy (CGT) sponsors are wrestling hard with how to prepare for having to make CMC changes throughout the development, submission, and post-approval stages, while facing accelerated timeframes and significant knowledge limitations.
CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies
September 28, 2019
Reviewers with FDA’s Center for Biologics Evaluation and Research (CBER) are working with sponsors to determine how and where flexibility can be applied in the type and extent of CMC information expected at the time of cell and gene therapy (CGT) product submissions.
CBER and CDER Directors Offer Insights on Overcoming Hurdles to Biomanufacturing Innovation at NIIMBL Annual Meeting
September 17, 2019
Among the ways that public/private collaborations could play a critical role in advancing cell and gene therapy (CGT) manufacturing would be helping create a non-proprietary set of adeno-associated virus (AAV) vectors, CBER Director Peter Marks proposed at the third annual meeting of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), held in Crystal City
Regulators and Industry Are Probing More Deeply into the Complexities of Preservative Usage
August 28, 2019
Regulators and industry are exploring more deeply the complex web of issues involved with effective use of preservatives in drug products, as the challenges and the consequences come into clearer view.
KASA and PQ/CMC Initiatives Gain Momentum in FDA’s Effort to Strengthen Quality Review Process
August 11, 2019
The efforts of FDA’s Office of Pharmaceutical Quality (OPQ) to standardize and streamline the CMC information in applications and how it is reviewed – initially for abbreviated new drug applications (ANDAs), and eventually for NDAs, and even biological license applications (BLAs) – is beginning to take concrete form.
EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment
July 26, 2019
EMA’s draft guideline on quality requirements for drug-device combination (DDC) products provides a template for the new concept of the notified body opinion (NBOp), intended to help ensure a consistent interpretation by individual assessors, notified bodies, and industry.
IPEC Continues to Encourage China to Align with Global Science-Based Excipient Standards
July 22, 2019
Global excipient manufacturers, working through the International Pharmaceutical Excipients Council (IPEC) Federation and IPEC-China, continue to express concern with the divergence of the Chinese Pharmacopeia (ChP) standards from the major global pharmacopeias, and to propose science-based changes that would move the ChP toward better alignment.
MHRA Inspectors are Advocating Data Mapping as a Key First Step on the Data Integrity Pilgrimage
June 13, 2019
Data process mapping is being strongly encouraged by inspectors from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a first step in planning, establishing, and maintaining the controls necessary to secure data integrity.
Data Integrity Compliance Experts Are Urging Industry to Apply Regulator Perspective and Learnings in Refining Data Systems and Auditing
May 29, 2019
Data integrity (DI) regulatory compliance experts are observing that industry in-house and third-party auditors are often not detecting failures because they are not viewing the systems and processes in the same manner as agency inspectors.
The Role of Quality Culture in Data Integrity Is Getting More Attention as Regulator and Industry DI Guidances Evolve
May 17, 2019
The importance of quality culture is finding more clear expression in the refinement of regulator and industry guidances that have been forthcoming recently on data integrity (DI) and what is required to assure it.
Data Integrity Guidance Revisions by FDA and PIC/S Deepen Industry’s DI Resource Pool
April 23, 2019
Updated guidances from FDA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on maintaining data integrity (DI) across the product lifecycle have deepened the pool of resources that industry now has available to support its DI efforts.
Cell and Gene Therapy Initiatives Prominent on Biomanufacturing Agenda of U.S. National Institute of Standards and Technology
March 27, 2019
The growing need for standards in the rapidly evolving world of biopharmaceuticals and cell and gene therapies (CGTs) is giving rise to an expanding array of collaborative initiatives, products, and processes, many of which are flowing through the U.S. National Institute of Standards and Technology (NIST).
FDA’s Focus Has Sharpened on Water Systems in the Wake of Nonsterile Product Microbial Contamination
March 11, 2019
FDA has been sharpening its focus on water systems during inspections of nonsterile liquid products as microbial contamination problems of significance in these products continue to surface.
Pharmacopoeia/Industry/Agency Global Dialogue on Compendial Compliance and Harmonization Continues, with Medicine Availability at Stake
February 15, 2019
Industry, regulatory authorities and pharmacopoeias continue to explore ways to address the difficult challenges of complying with and harmonizing compendial and regulatory requirements in the effort to ensure and enhance the availability of medicines around the world.
FDA Investigators Will Focus on Simple GMP Lapses when Inspecting Complex Biotech Systems, Former Compliance Official Cosgrove is Advising
February 12, 2019
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
Gates Foundation’s Expanded Commitment to Global Medicines Encompasses CMC/Regulatory Problem Solving
January 27, 2019
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
January 15, 2019
The “strategic priorities” of the Office of Pharmaceutical Quality (OPQ) for the next few years speak to the wide 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
January 11, 2019
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”
January 10, 2019
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
January 7, 2019
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.
Emergency Preparations Draw Heightened Industry and Regulator Attention as Natural and Man-Made Disasters Proliferate
December 27, 2018
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 are being addressed.
CBER’s Compliance Office Absorbing Impact of Cell/Gene Therapy Wave in its Pre-Market and Surveillance Operations
November 20, 2018
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
November 12, 2018
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
October 22, 2018
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).
Refined Training, Project Selection, and Membership Processes Strengthen ICH’s Global Harmonization Efforts
September 6, 2018
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.

● Updates in Brief	● FDA Warning Letters
● EMA Non-Compliance Reports	● FDA Drug Recalls

IPQ would like to thank our partners: