PDUFA

Category archives for PDUFA

by Susan F. Wood, PhD  It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA.  The recently released report (PDF) by the Subcommittee on Science and Technology for the FDA Science Board does just that.  Although I wouldn’t necessary agree with all of…

FDA Advisory Committees: One Person, One Vote

by Susan F. Wood, PhD  FDA recently announced two draft guidances regarding advisory committees, one on public disclosure of financial conflicts of interests and the other on voting procedures.   

Congress’s FDA Bill Includes Reforms

The House and Senate have both passed legislation that renews the FDA’s user-fee system and enacts some important reforms. The process has been rushed because FDA is running dangerously low on funds; President Bush will need to sign the legislation today if the FDA is to avoid sending termination letters to one-fourth of its staff.…

 By Susan F. Wood, PhD  Two things appear to be major bones of contention in determining the final version of what is now named the “FDA Revitalization Act of 2007″ (FDARA).  And they both related to public transparency and public accountability. 

 By Susan F. Wood, PhD  In an article in the New England Journal of Medicine today, Sheila Weiss Smith points out that the FDA has not been responsive to the Institute of Medicine (IOM) report on Drug Safety.  That study and its recommendations took on the question of how to improve our nation’s drug safety…

 By Susan F. Wood, PhD  The Journal of Women’s Health published a special report and an editorial last month on the FDA’s Office of Women’s Health (FDA OWH) that provide information and insight into the multiple roles of such an office, and the importance of maintaining the scientific research funded there.  The special report, “The…

Transparency, strength at the FDA

The Boston Globe, home town paper of  Senator Ted Kennedy, Chair of the Senate Health, Environment, Labor and Pensions Committee, ran two important commentaries on the FDA this week.  First was an editorial  yesterday strongly urging Congress to pass a strong FDA reform bill, including restricting financial conflicts of interests for advisory committee members. Today the…

Friday Blog Roundup

This week, Congress has been wrestling with the reauthorization of the Prescription Drug User Fee Act; Merrill Goozner at GoozNews reports from Capitol Hill about the questions that FDA Acting Deputy Commissioner for Policy Randall Lutter couldn’t answer at a hearing and about the provisions that should be in the bill but aren’t. Matt Madia…

By Susan Wood The recent study in the NEJM clearly points out that our drug safety system is in need of repair.  We shouldn’t need these constant reminders, from Vioxx to Ketek and now to Avandia.  Indeed FDA reform legislation is moving through Congress as we speak.  But does it do what we need it…

Who Supports FDA User Fees?

When you go to the Department of Motor Vehicles and pay your fee to register your car, are you allowed to negotiate with the DMV as to how the agency will use your fee? Of course not. So why is the drug industry allowed to negotiate with the FDA about how the agency will use…