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  1. Regulations
    All Titles
  2. title 21
    Food and Drugs
  3. chapter I-i4
    CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
  4. part 314
    PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Part 314. PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

  • SUBPART A [§ 314.1 - § 314.3] - Subpart A—General Provisions
  • SUBPART B [§ 314.50 - § 314.90] - Subpart B—Applications
  • SUBPART C [§ 314.92 - § 314.99] - Subpart C—Abbreviated Applications
  • SUBPART D [§ 314.100 - § 314.170] - Subpart D—FDA Action on Applications and Abbreviated Applications
  • SUBPART E [§ 314.200 - § 314.235] - Subpart E—Hearing Procedures for New Drugs
  • SUBPART F - Subpart F [Reserved]
  • SUBPART G [§ 314.410 - § 314.445] - Subpart G—Miscellaneous Provisions
  • SUBPART H [§ 314.500 - § 314.560] - Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
  • SUBPART I [§ 314.600 - § 314.650] - Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
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