Drugs

Industry Letters

Below is a sortable listing of Industry Letters Guidances:

CategoryTitleTypeDate
Industry Letters Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program (PDF - 611KB) Final Guidance 03/02/98
Industry Letters Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required (PDF - 243KB) Final Guidance 03/02/98
Industry Letters Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I (PDF - 839KB) Final Guidance 03/02/98
Industry Letters Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance (PDF - 644KB) Final Guidance 03/02/98
Industry Letters Implementation Plan USP injection nomenclature (PDF - 247KB) Final Guidance 03/02/98
Industry Letters Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C (PDF - 730KB) Final Guidance 03/02/98
Industry Letters Sixth of a series of informal notice letters about the Act discussing 3-and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act (PDF - 538KB) Final Guidance 03/02/98
Industry Letters Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) (PDF - 740KB) Final Guidance 03/02/98
Industry Letters Third of a series of letters regarding the implementation of the Act (PDF - 393KB) Final Guidance 03/02/98
Industry Letters Year 2000 Letter from Dr. Janet Woodcock Final Guidance 10/19/98

Page Last Updated: 07/10/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.