Article preview from "The Gray Sheet" - September 21, 2009
Two key proposed rules from FDA's Office of Combination Products have finally received Office of Management and Budget approval and should be out for comment in the coming weeks, according to OCP Director Thinh Nguyen. Read more...
Combination Product Rules Clear OMB, To Be Released In Weeks
Article preview from "The Gray Sheet" - September 21, 2009
Two key proposed rules from FDA's Office of Combination Products have finally received Office of Management and Budget approval and should be out for comment in the coming weeks, according to OCP Director Thinh Nguyen.
Release of the proposed rules on current good manufacturing practices (cGMP) and adverse event reporting for combination products has been repeatedly delayed, most recently by the change in FDA leadership under the Obama administration.
But, says Nguyen, thanks to a push from former acting and now Principal Deputy Commissioner Joshua Sharfstein, companies will see the rules in the Federal Register very soon.
"That's one thing we asked for his help on," Nguyen said Sept. 15 at the Regulatory Affairs Professionals Society annual meeting in Philadelphia. "It's moving much faster under his watch."
Makers of combination products say they need the rules - about four years in the making - to guide decisions about how to set up manufacturing facilities and procedures, among other things (1 'The Gray Sheet' Feb. 23, 2009).
"It's a major step," said regulatory law expert Jim Cohen, of the firm Buchanan Ingersoll and Rooney, at the RAPS meeting.
Once the proposed cGMP rule comes out, the Combination Product Coalition trade group plans to organize a public meeting with FDA and regulatory professionals to discuss the reg and work through real-world case studies, CPC's Brad Thompson, partner at Epstein Becker and Green, said at the meeting.
- Jessica Bylander
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