Biotech Values

[DewDiligence]

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.