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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER A—GENERAL
  6. PART 4—REGULATION OF COMBINATION PRODUCTS

21 CFR Part 4 - PART 4—REGULATION OF COMBINATION PRODUCTS

  • CFR
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  1. Subpart A—Current Good Manufacturing Practice Requirements for Combination Products (§§ 4.1 - 4.4)
  2. Subpart B—Postmarketing Safety Reporting for Combination Products (§§ 4.100 - 4.105)
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360b–360f, 360h–360j, 360l, 360hh–360ss, 360aaa–360bbb, 371(a), 372–374, 379e, 381, 383, 394; 42 U.S.C. 216, 262, 263a, 264, 271.
Source:
78 FR 4321, Jan. 22, 2013, unless otherwise noted.

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