Cross-posted from Pfizer's Think Science Now
My colleague in Regulatory Affairs, Dr. Sharada Truter, was good enough to share the following regarding a Perspective published last week in the New England Journal of Medicine:
FDA Commissioner Margaret Hamburg and NIH Director Francis Collins write that the initiatives will support the advancement of personalized medicine through rapid development, review and approval of safe and effective genetics-based disease therapies.
More specifically, the NIH initiative calls for the agency to invest in research that will support scientists’ efforts to translate genetic-marker discoveries into effective diagnostic tests and disease therapies, while the FDA’s program will work to develop an effective and timely pathway for the review and approval of new gene-therapy drugs.
The full-text of the NEJM article is available at this link.