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Drugs

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Industry Letters

 Title and Format  Type  Issue Date
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 - 611 KB) Final Posted 3/2/1998
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 - 243 KB) Final Posted 3/2/1998
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 - 839 KB) Final Posted 3/2/1998
Implementation of the Drug Price Competition and Patent Term Restoration Act.(PDF - 644 KB)  Preliminary Guidance  Final Posted 3/2/1998
Implementation Plan USP injection nomenclature (PDF - 247 KB) Final Posted 3/2/1998
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 - 730 KB) Final Posted 3/2/1998
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 - 538 KB) Final Posted 3/2/1998
Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) (PDF - 740 KB) Final Posted 3/2/1998
Third of a series of letters regarding the implementation of the Act (PDF - 393 KB) Final Posted 3/2/1998
Year 2000 Letter from Dr. Janet Woodcock Final 10/19/1998
    
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