Regulatory Affairs Editorial
-
How To Educate Regulators On What Matters To Patients
12/13/2022
With the greater emphasis on patient-centricity, patients are valued as an active participant in their own care. There is an increased emphasis on evaluating treatment benefit using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to systematically engage patients and caregivers to define the disease burden and unmet needs.
-
3 Tips To Navigate The Increasingly Complex PVA Landscape
12/8/2022
The shifting landscape of industry innovation and unconventional partnerships has created a need for an increased number of pharmacovigilance agreements (PVAs) with higher levels of complexity. As a result, many stakeholders face new challenges in drafting, negotiating, and finalizing PVAs.
-
Survey Reveals High Levels Of CTIS Adoption In Europe
11/8/2022
Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.
-
India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
11/7/2022
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
-
FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics
10/20/2022
The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.
-
Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations
10/14/2022
This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.
-
FDA’s RTOR Program: Draft Guidance & Insights
10/4/2022
First launched in Feb. 2018 by the FDA’s Oncology Center of Excellence, the Real-Time Oncology Review (RTOR) program is intended to streamline the review process for oncology drug applications. This article summarizes the new guidance and reviews the performance of the program thus far.
-
RWD/RWE: To Replicate Or Continue To Learn In The Real World?
6/23/2022
In addition to using real-world evidence (RWE) for clinical- and cost-effectiveness, it is also now being used for regulatory reviews of safety, efficacy, and quality. This article covers different types of decision-making using RWD/RWE across pharma companies, healthcare providers (HCPs), healthcare systems, payers and health technology assessment (HTA) agencies, regulators, and patients.
-
IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy
6/1/2022
European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.
-
FDA Releases Draft Guidance On Clinical Recommendations For “N of 1” Gene Therapies
3/15/2022
To eliminate ineffectiveness due to genetic differences, clinical trials of individual patients, described as an “N of 1” (single-subject) trial, can provide crucial insight. The regulatory path for conducting such gene therapy trials has been difficult to ascertain until now. This article shares the key takeaways of the FDA's draft guidance and provides an analysis for moving forward.