Regulatory Focus™ > News Articles > Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

Updated: FDA to Testify Before Senate Hearing on PDUFA, MDUFA

Posted 28 March 2012 | By Alexander Gaffney, RAC 

[Editor's note: an earlier draft of this article incorrectly claimed the hearing was on 28 March. The hearing is being held on 29 March, 2012]

A Senate hearing is scheduled to hear testimony Thursday(29 March) on the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA), marking the first hearing on either piece of legislation in the Senate.

Directors Janet Woodcock of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and Jeffery Shuren of FDA's Center for Devices and Radiological Health (CDRH) are set to testify before the Senate Health, Education, Labor and Pensions (HELP) Committee during the first session of the hearing.

A second panel of witnesses will include experts from the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), the Generic Pharmaceutical Association (GPhA), the Advanced Medical Technology Association (AdvaMed) and The Pew Charitable Trusts.

The hearing will start at 10:00 PM EST on 29 March 2012, and likely last until around 3:00 PM.

Read more:

Senate HELP Committee - FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients

Previous Regulatory Focus coverage of PDUFA 

Previous Regulatory Focus coverage of MDUFA

Regulatory Focus newsletters

All the biggest regulatory news and happenings.