Generic Drug Development: A Guide to FDA Regulation

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Generic Drug Development
A Guide to FDA Regulation

Attention generic drugmakers: The FDA wants to make your job easier!

Lowering drug prices is a major goal for FDA Commissioner Scott Gottlieb. He’s targeted the advancement of generic drug development as part of the solution.

With this comes new guidances… policies… and initiatives to speed generic drug approval and help generics companies get past the traditional barrier that limit their competitiveness.

With a strategic development plan you can profit from these developments. But, first you need to do the research.  That can mean hours of searching for all the new guidances, programs, information sheets, forms and instructions you need to navigate the FDA’s approval process.

Generic Drug Development contains all of the FDA’s generics-related guidances, plus internal agency policies on reviewing applications, instructions for challenging patents and even lists of branded drugs with expired patents and no generic competition. In this report you’ll find information on:

  • User fees
  • Pre-submission meetings
  • Controlled correspondence
  • Bioequivalence
  • ANDA content and format
  • Paragraph IV patent certification
  • FDA review and approval

The report also includes:

  • ANDA submission forms and requirements
  • List of first generic drug approvals in 2017
  • List of Paragraph IV patent certifications
  • FDA GDUFA II commitment letter

Order your copy of Generic Drug Development: A Guide to FDA Regulation andlet the experienced researchers and reporters of FDAnews do the work for you so you can focus on how your company can cash in on this new pro-generics era.

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Who Will Benefit

  • Regulatory affairs
  • Research and development
  • Senior executives
  • Legal counsel

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