Regulatory Affairs Editorial
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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FDA Releases Draft Guidance On Decentralized Clinical Trials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The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices.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.
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FDA's Digital Health Technologies Framework Addresses Important Challenges
5/16/2023
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
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A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
5/16/2023
The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.
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Why Clinical Site Awareness Should Be "Day Zero" For SUSAR Reporting
5/3/2023
Ask a handful of clinical research professional about the determination of "Day Zero" when reporting a suspected, unexpected, serious adverse reaction (SUSAR), and you may get a variety of answers. While sponsors are ultimately responsible for SUSAR reporting adherence, Penelope Przekop contends that clinical sites should be the ones that start the clock when it comes to meeting regulatory timelines.
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Project Orbis For Cell & Gene Therapies Gathers Momentum
4/25/2023
Project Orbis has worked very well for oncology products. CBER Director Dr. Peter Marks has recently started promoting the development of a similar program, which would coordinate review with other regulators, for cell and gene therapies. This would be an enormous step forward.
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New FDA Guidance: Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics
4/21/2023
On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). The move highlights some of the limitations that have been identified with the accelerated approval pathway and provides insight into the rationale for new FDA draft guidance.
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Congressional Changes For Orphan Drug Approvals?
4/18/2023
Lawmakers are stepping in to increase the number of rare disease and orphan drug experts who sit on advisory committees. As it stands now, advisory committees can include experts who simply have a broad understanding of the overall disease state.
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New DSCSA Compliance Blueprint Includes FDA & Industry Input
4/12/2023
Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.
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Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.