Regulatory Affairs Editorial
-
FDA Issues New Guidance On Dose Optimization For Oncology Therapies
2/9/2023
In January 2023, the FDA issued a new draft guidance document on optimizing the dosage of drugs and biological products for the treatment of oncologic diseases. Marjorie E. Zettler, Ph.D., MPH, executive director of clinical science at Regor Pharmaceuticals, summarizes its recommendations.
-
The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act
2/7/2023
With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.
-
The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups
1/19/2023
How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.
-
FDA Releases Final Guidance On Early-Phase Cell & Gene Therapy Trials
1/18/2023
The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.
-
Avoid Launch Delays By Planning For An FDA-Required REMS
1/13/2023
Picture this: The FDA accepts a manufacturer's NDA, and the manufacturer plans for its impending launch. But shortly before the anticipated approval, the FDA notifies the manufacturer that a Risk Evaluation and Mitigation Strategy (REMS) program is required to market the product. Now what?
-
FDA Adopts ICH Final Guidance On Bioanalytical Method Validation
1/11/2023
The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.
-
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.
-
Needed: An AI Revolution In The Rare Disease Space
11/11/2022
Quris has developed a treatment for Fragile-X Syndrome, the most common inherited cause of autism and intellectual disabilities worldwide. Isaac Bentwich M.D., the founder and CEO of Quris, believes the rare disease space, in general, is a difficult one to navigate.
-
LATAM’s Regulatory Framework For Medtech Early Feasibility Studies
11/11/2022
Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.