US FDA seeks input on nanotechnology guidelines
This article was originally published in Scrip
The US FDAwill gather public comments and data at a September 8th meeting to aid the development of guidelines for nanotechnology products. Last year an agency task force report recommended development of various guidance documents on the use of nanoscale materials (Scrip Online, July 26th, 2007). These included guidelines for sponsors on identifying the particle size for drugs and biologicals, and for submitting information on how nanoscale materials affect the manufacturing process. The meeting's primary purpose is to determine what factors the FDA should consider in providing guidance on the information and data needed to demonstrate safety and effectiveness of products containing nanoscale materials, and the circumstances under which a product's regulatory status might change owing to the presence or use of nanoscale materials.
You may also be interested in...
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."
Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.
Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.