FDA's Chief Scientist Reveals Planned Animal Rule Revisions, Regulatory Science Initiatives
Posted 03 May 2012 | By
US Food and Drug Administration's (FDA) Chief Scientist Jesse Goodman gave a presentation to FDA's Science Board on 2 May, laying out a number of upcoming FDA activities and priorities including the agency's planned revision of its Animal Rule draft guidance and a number of new regulatory science initiatives.
Goodman noted FDA has selected three projects from a pool of 35 applicants for its regulatory science Challenge Grant program. The three projects aim to create biomarkers for the detection of Creutzfeldt-Jakob disease in tissue and blood donations, the detection of food allergens, and the detection of drug-induced liver injury.
Goodman also touted the successes of FDA's Medical Countermeasures Initiative (MCMi), which he attributed a number of accomplishments. Among the successes listed by Goodman include the development of legislative proposals to improve emergency preparedness, the publication of a paper on a novel regulatory approach for multiplex diagnostic tests, planning future regulatory science investments and the launch of a program to qualify animal models to be used for submissions.
The MCMi has a number of ongoing and upcoming activities, said Goodman, which include the establishment of "best review practices" for MCMi products across numerous FDA centers, revising FDA's Animal Rule draft guidance, implementing a program for qualifying animal models, developing novel manufacturing platforms and developing advanced diagnostic tests.
Goodman's presentation also addressed the White House Office of Science and Technology's (OST) National Bioeconomy Blueprint, in which OST called for a number of changes at FDA.
Goodman offered up a number of areas in which he believed FDA could make changes to help the US bioeconomy, including the increased use of large data sets to speed up the development of medical products, the increased adoption of cutting-edge genomics research and stem cell research to identify "emerging microbial threats" and treat new diseases, increase regulatory predictability at FDA, increase FDA's ties to government and industry stakeholders, and support public-private partnerships and precompetitive collaborations.
FDA - Science at FDA: Update for the FDA Science BoardRegulatory Focus - New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices