InvestorsHub Logo
Post# of 253152
Next 10
Followers 840
Posts 120462
Boards Moderated 18
Alias Born 09/05/2002

Re: jq1234 post# 135027

Wednesday, 08/31/2016 4:08:47 PM

Wednesday, August 31, 2016 4:08:47 PM

Post# of 253152
GDUFA reauthorized for FY2018-FY2022; this is GPhA’s statement:

http://www.gphaonline.org/gpha-media/press/gpha-statement-on-the-generic-drug-user-fee-amendments

“GPhA and its members are pleased to conclude the first reauthorization negotiations to update the Generic Drug User Fee Amendments (GDUFA).

…Key provisions of GDUFA II include:

• GDUFA Backlog ANDA Provisions
• Priority and Standard Review
• Enhanced communication and transparency
• Complex Product Meetings
• Enhancements to the Inactive Ingredient Database (IID)
• Resource Management and Planning and Performance Reporting
• Small Business Relief

GPhA is optimistic that the provisions of this agreement will streamline approvals by assigning goal dates to all ANDAs to assure that no submissions from GDUFA I are left behind. It will also provide the FDA with additional resources, improving transparency and accountability in order to enhance the ability of the FDA to meet GDUFA II goals. Process changes and staff additions have been positive steps thus far, and the addition of enhanced performance reporting sets an even stronger foundation for translating FDA actions on generic applications to approvals.


“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Join InvestorsHub

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.