Accelerate Your Understanding of Accelerated Approvals; Navigating The FDA Accelerated Approval ProcessNovember 19, 2010
On December 9, 2010, Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will speak at a webinar on accelerated drug and biologic approvals.
In 1992, FDA published final regulations providing for the “accelerated approval” of applications for certain new drugs and biologics. Section 506 of the FDC Act, created in 1997, codified and expanded on FDA’s Accelerated Approval regulations. Both provisions include requirements for sponsors to conduct post-approval studies. Fast track and “accelerated approval” are conditioned on a sponsor’s commitment to timely complete required postmarketing studies to demonstrate the product’s clinical benefits. FDA may expedite the withdrawal of approval of an application if a sponsor fails to perform the required postmarketing study with due diligence, or if a postmarketing clinical study fails to verify clinical benefit. FDA has approved scores of products under both the fast track and accelerated approval procedures, but has never withdrawn approval for a sponsor’s failure to conduct post-approval studies. Only recently has FDA threatened to do so.
The December 9th webinar is titled “Navigating The FDA Accelerated Approval Process” and will be moderated by Pharmalot’s Ed Silverman. Additional information on the webinar, including how to register, is available here.