BioCentury reports that, per meeting minutes released by the FDA on Thursday and Friday, the agency and industry have an agreement for PDUFA V. On the financial front, "Industry agreed to include the $65 million in additional fee revenues for drug safety in FY 2012 in the base fee revenue amount for PDUFA V.”
Next step is for the FDA to hand its draft PDUFA V recommendations to the White House for review. Then, if all goes according to plan, the agency hopes to transmit its final PDUFA V recommendations to Congress on Jan. 15, 2012.
And yet, curiously, CDER Deputy Director Doug Throckmorton (PS/one of the smartest and hardest working guys at the agency) announced that the FDA will hold a PDUFA Public Meeting in September to get more input.
Hm.
On a separate but related note, the FDA has begun a review of its regulatory operations to determine if they can be made more effective. The agency is requesting comments on whether existing rules are "outmoded, ineffective, insufficient, or excessively burdensome."
Ya think?
The review is being conducted in response to an executive order issued by President Obama in January and the deadline for comments is June 27.
So stop griping and start typing.
