Regulatory Affairs Editorial
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Securing FDA Expanded Access Designation For An Emergent Public Need
6/26/2023
In this Q&A, SIGA Technologies Executive Vice President and Chief Scientific Officer Dennis Hruby discusses the journey toward expanded access, or compassionate use, of TPOXX and the importance of keeping a pulse on — and reacting to — an emerging public need.
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An Agile Approach To Regulatory Information Management System Transformation
6/20/2023
Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically.
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FDA Seeks Input On AI Adoption In Drug Development And Manufacture
6/13/2023
The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.
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What Sponsor Companies Need To Know About The Updated DOJ Corporate Compliance Programs
6/13/2023
In March 2023, the criminal division of the U.S. Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs document to serve as a guide for prosecutors in assessing the effectiveness of a company's compliance program.
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The Business Case for Healthcare Compliance Programs for Emerging Companies
6/9/2023
For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead.
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Considerations For Compliance With CTIS Submissions Under The EU-CTR
5/31/2023
This article outlines the process for sponsors in transitioning from an EU-CTD to an EU-CTR CTIS submission process. It provides guidance on redacting both personal data and confidential commercial information (CCI) appropriately, with detailed advice on how to identify and assess CCI for redaction, as well as strategies for minimizing the risk.
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How Predictive Can Regulatory Drug Abuse Potential Investigations Be in Animals?
5/31/2023
Is addiction attributed to “the animal or the human within us” or is substance abuse unique to humans? This question has intrigued me since the EMA guidance on Non-clinical Investigation of the Dependence Potential of Medicinal Products in 2006 and the FDA guidance on Assessment of Abuse Potential of Drugs in 2010 have requested the performance of dedicated studies in animals. Let's take a closer look at the matter.
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Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act
5/23/2023
The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
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Reflecting On The Syneos Health Acquisition: The Due Diligence Imperative
5/22/2023
Syneos Health made headlines when it announced it may soon be acquired by a private equity consortium for approximately $7.1 billion. This transaction represents an exciting opportunity for both parties, but it also underscores the importance of thorough due diligence to ensure that the acquiring party maximizes value from the target entity.
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FDA Releases Draft Guidance On Decentralized Clinical Trials
5/18/2023
The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.