And, according to the Federal Register, Jupiter aligns with Mars.
It seems that peace, love and happiness have broken out.
As BioCentury reports:
BIO and PhRMA have reached a final agreement with FDA on terms for reauthorizing PDUFA, according to sources involved with the negotiations. The final element of the deal, language committing FDA to "promoting innovation through enhanced communication" with sponsors during drug development, was agreed upon this week. Previously agreed elements of PDUFA V include two-month extensions on standard and priority PDUFA review goals, and user fee funding for 119 new FDA staff for regulatory science projects. The five-year PDUFA V cost is expected to be about $3 billion, up from about $2.8 billion for PDUFA IV.
FDA has agreed to adopt a "philosophy statement" committing the agency to "timely interactive communications with sponsors during drug development." A PDUFA V goals letter commits FDA to develop, by the end of FY13, a dedicated staff to liaise with sponsors during the IND process and to train CDER staff on best practices for enhanced communication with sponsors.
The two-month extensions of review goals will provide time for FDA to incorporate two new elements: a status update for sponsors in the middle of a review, and a late-cycle meeting in advance of any advisory committee meeting to present a comprehensive report on the agency's review.
FDA is expected to publicly release the PDUFA V agreement following review by HHS and the Office of Management and Budget, and to hold a public hearing in October. The House Energy and Commerce and Senate Health, Education, Labor and Pensions committees have tentatively scheduled hearings on PDUFA in June.
And in other news of mutual admiration and respect:
Midthun to allow discussion of future Avastin studies at hearing
CBER Director Karen Midthun indicated she will allow Genentech Inc. to present information about future studies of Avastin bevacizumab at a June 28-29 hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label. In a letter to the Roche unit and CDER, Midthun said it is not appropriate to exclude the information since CDER does not dispute the validity of the evidence, only its relevance. She added that she is not prepared to rule at this time on whether or not the information is relevant to the hearing.
Last week, CDER said in a letter to Midthun that it did not believe future studies of Avastin were within the scope of the hearing.
Harmony and understanding?
Is this the dawning of a regulatory Age of Aquarius?
