Regulatory Affairs Editorial
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A Stem Cell Company Overcomes The Challenges Of International Trials
8/26/2021
Performing global trials presents challenges that drug developers do not face in the U.S. Those challenges need to be considered and addressed in the planning process. Jim Joffrion, senior director of clinical development and operations for Athersys, discusses the challenges and the importance of the CRO selection process.
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3 Steps To Getting Your First Decentralized Trial Greenlit & Executed
8/17/2021
Decentralized trials are complex, yes, but they are just a different kind of complex. Halloran Consulting unpacks the top three strategies to consider before you begin your decentralized trial design and champion your vision to executives.
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TransCelerate BioPharma & CDISC Collaborate On SAE Data Collection Standard
6/22/2021
There has been a lack of standardization across the data fields collected on serious adverse events (SAE) case report forms. TransCelerate BioPharma wanted to change that. The end result is a standard that the biopharma R&D industry could follow to increase the quality and comprehensiveness of SAE reports.
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ICER: FDA Has Failed In Its Responsibility To Protect Patients From Harm
6/15/2021
A recent report from Bloomberg Intelligence was not kind to the FDA’s approval of aducanumab for the treatment of patients with Alzheimer’s. A white paper released by the group states the approval would be met with more questions than answers and could bring a loss of credibility to the regulatory agency. Now, the Institute for Clinical and Economic Review (ICER) has issued a statement on the approval, which is no kinder to the agency or its approval.
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What Does Biogen’s Drug Approval Mean For Alzheimer’s Patients?
6/8/2021
The FDA’s approval of aducanumab for patients with Alzheimer’s disease seems to have surprised some in the industry. There are several take-aways from the decision, and senior industry analysts Marc Engelsgjerd and Sam Fazeli of Bloomberg Intelligence have captured those ideas in a new white paper.
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Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
5/5/2021
With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.
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Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
5/5/2021
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.
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How To Navigate Compliance With FDA’s 21 CFR Part 11
4/7/2021
21 CFR Part 11, the FDA's regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance at CROs and pharma companies. How can you ensure compliance with this regulation?
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The Asia-Pacific Region: A Hot Spot For Clinical Trials
3/2/2021
The Asia-Pacific region has become the hot spot for conducting clinical trials. Why? There is an ease of regulatory compliance, a low cost of conducting studies, a growing patient population, and the presence of a few top clinical institutions acting as sites.
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An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials
2/2/2021
An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.