Drugs

Ways for FDA to Modernize Biotech Regulation

The National Security Commission on Emerging Biotechnology (NSCEB) says FDA’s oversight of medical products through CBER, CDER, and CDRH “has largely been successful for traditional products but is increasingly inefficient when applied to innovative medical products.” In a report, “Modernizing Medical Biotechnology Regulation,” NSCEB says FDA regulatory frameworks were built for well-characterized small-molecule drugs, and the agency struggles to adapt to biotechnology-enabled medical products such as cell and gene therapies.

The report describes 22 policy options across five key areas to improve the regulation of biotechnology medical products:

Ensure Predictable and Transparent Reviews
- finalize and expand the platform technology designation;
- help developers meet data expectations;
- align evidentiary standards and review practices;
- establish a regulatory sandbox for medical biotechnology products;
- validate modern testing methods.
Conduct Faster, Fairer Clinical Trials
- require centralized review for multi-site trials;
- allow trial designs for small populations;
- align endpoints and biomarkers across FDA;
- remove barriers to speedy Phase 1 trials;
- remove barriers to insurance cost-sharing.
Hire, Train, and Retain Regulators
- target workforce gaps with existing tools;
- tie career progression to continuing education;
- rebuild FDA’s internal policy capacity.
Build a Connected FDA with Modern Integrated Systems
- build a single FDA enterprise system;
- leverage FDA data to support innovation and safety;
- harmonize technology across agencies;
- support strong participation in international standard-setting.
Promote Efficient Manufacturing
- expand risk-based inspections overseas;
- clarify manufacturing requirements;
- coordinate country-of-origin labeling;
- expand domestic manufacturing capacity and workforce.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome