Regulatory Affairs Editorial
-
WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
-
Trip Or No Trip: Pharmas Are Taking Psychedelic Trials To Australia
12/13/2023
Enveric Biosciences CEO Joseph Tucker, Ph.D., chronicles the company's quest for regulatory approval in Australia, as well as navigates the unknowns of developing psychedelics for therapeutic use.
-
Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality
12/12/2023
Could your director of clinical operations or TMF manager identify all customers of the TMF? Perhaps not. Learn why knowing all customers is so important to efficient, high-quality trials.
-
Are Your Trials Compliant With The Updated Physician Payments Sunshine Act?
12/7/2023
Sponsors must proactively mitigate Sunshine Act compliance risks by conducting thorough internal audits, reevaluating policies and procedures, and ensuring all financial interactions with healthcare providers align with legal and ethical standards.
-
FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities
12/5/2023
In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.
-
Improving Clinical Trials Accessibility For Patients With Disabilities
11/29/2023
While increasing DE&I in clinical trials is essential to all individuals, this article speaks to considerations for removing barriers and improving trial accessibility for individuals with disabilities. Discussion includes combating stigma and bias, changing structural design, and more.
-
Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
11/20/2023
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
-
Do We Need An IRB/IEC Revolution?
11/10/2023
Are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) the same? And if they're not, how are they different? Kamila Novak of KAN Consulting helps define the two bodies and their roles across the globe, as well as explains how we might rethink their roles in the future.
-
Legal And IP Protection For New Biotechs
10/31/2023
Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs.
-
Impact Of Research Misconduct Updates On Clinical Trial Sponsors
10/31/2023
The Office of Research Integrity (ORI) has proposed updates to the Public Health Service Policies on research misconduct. Darshan Kulkarni outlines how the new proposals should influence sponsors to reevaluate their existing clinical trial practices and policies.