Regulatory Affairs Editorial
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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.
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A Clinical Setback Leads To A Transformation And A New Trial
1/12/2021
Pharnext is a small pharma company which faced adversity and was able to overcome it. The setback occurred in 2019 when data produced from a Phase 3 trial was rejected by the FDA. That forced the company to make a leadership change and regroup.
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FDA’s Office Of Minority Health And Health Equity Addresses Patient Diversity
12/8/2020
The diversity of patients participating in clinical trials continues to be a problem in drug development. As sponsors and sites attempt to address the problem, regulators are also doing their best to address the issue. One person deeply involved in this issue is Rear Admiral Richardae Araojo, the associate commissioner for minority health and director of the Office of Minority Health and Health Equity at FDA.
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How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation
8/25/2020
Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. (Downloadable storyboard template included.)