Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES

PART 60--PATENT TERM RESTORATION

TEXT PDF60.1 Scope.
TEXT PDF60.2 Purpose.
TEXT PDF60.3 Definitions.
TEXT PDF60.10 FDA assistance on eligibility.
TEXT PDF60.20 FDA action on regulatory review period determinations.
TEXT PDF60.22 Regulatory review period determinations.
TEXT PDF60.24 Revision of regulatory review period determinations.
TEXT PDF60.26 Final action on regulatory review period determinations.
TEXT PDF60.28 Time frame for determining regulatory review periods.
TEXT PDF60.30 Filing, format, and content of petitions.
TEXT PDF60.32 Applicant response to petition.
TEXT PDF60.34 FDA action on petitions.
TEXT PDF60.36 Standard of due diligence.
TEXT PDF60.40 Request for hearing.
TEXT PDF60.42 Notice of hearing.
TEXT PDF60.44 Hearing procedures.
TEXT PDF60.46 Administrative decision.

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