Regulatory Affairs Updates: Latest on ANDA User Fees (GDUFA)
FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees for ANDA sponsors. As currently drafted, a one-time backlog fee is anticipated for “Each person...
View ArticleAs Expected, User Fee Bill Passes House Heads for Senate
The Food and Drug Administration Safety and Innovation Act (FDASIA) goes to the Senate for a vote next week after passing by a large margin in the House June 20. The new user fee legislation will...
View ArticlePharmaceutical Consultant’s Update on Smoking Cessation and Generic Drug...
As pharmaceutical consultants with a long history of work in smoking cessation and safety surveillance, PDG® is monitoring two pending proposed rules with great interest. The first is entitled Deeming...
View ArticleHelp With BPCA, PREA, Initial Pediatric Study Plans (iPSP), Deferral and...
As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their BPCA and PREA needs. This...
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