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20 results 379j-52
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Exact match Title 21 Title 21 / Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII GENERAL AUTHORITY / Part C Fees / Subpart 8 fees relating to biosimilar biological products / Section 379j–52

21 U.S.C. § 379j–52

Authority to assess and use biosimilar biological product fees

Part C Fees / Subpart 8 fees relating to biosimilar biological products

Exact citation match for 21 USC § 379J-52

Title 21 Title 21 / Section 379j–51

21 U.S.C. § 379j–51

Definitions

Part C Fees / Subpart 8 fees relating to biosimilar biological products

Definitions

Title 21 Title 21 / Section 379j–53

21 U.S.C. § 379j–53

Reauthorization; reporting requirements

Part C Fees / Subpart 8 fees relating to biosimilar biological products

Reauthorization; reporting requirements

Title 21 Title 21 / Section 379j–12

21 U.S.C. § 379j–12

Authority to assess and use animal drug fees

Part C Fees / Subpart 4 fees relating to animal drugs

Authority to assess and use animal drug fees

Title 21 Title 21 / Section 355h

21 U.S.C. § 355h

Regulation of certain nonprescription drugs that are marketed without an approved drug application

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Regulation of certain nonprescription drugs that are marketed without an approved drug application

Title 21 Title 21 / Section 379h

21 U.S.C. § 379h

Authority to assess and use drug fees

Part C Fees / Subpart 2 fees relating to drugs

Authority to assess and use drug fees

Title 21 Title 21 / Section 379j

21 U.S.C. § 379j

Authority to assess and use device fees

Part C Fees / Subpart 3 fees relating to devices

Authority to assess and use device fees

Title 21 Title 21 / Section 379j–1

21 U.S.C. § 379j–1

Reauthorization; reporting requirements

Part C Fees / Subpart 3 fees relating to devices

Reauthorization; reporting requirements

Title 21 Title 21 / Section 379j–41

21 U.S.C. § 379j–41

Definitions

Part C Fees / Subpart 7 fees relating to generic drugs

Definitions

Title 21 Title 21 / Section 379j–42

21 U.S.C. § 379j–42

Authority to assess and use human generic drug fees

Part C Fees / Subpart 7 fees relating to generic drugs

Authority to assess and use human generic drug fees

Title 21 Title 21 / Section 379j–43

21 U.S.C. § 379j–43

Reauthorization; reporting requirements

Part C Fees / Subpart 7 fees relating to generic drugs

Reauthorization; reporting requirements

Title 21 Title 21 / Section 379d–3

21 U.S.C. § 379d–3

Streamlined hiring authority

Subchapter VII GENERAL AUTHORITY / Part A General Administrative Provisions

Streamlined hiring authority

Title 21 Title 21 / Section 301

21 U.S.C. § 301

Short title

Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter I SHORT TITLE

Short title

Title 21 Title 21 / Section 360e–1

21 U.S.C. § 360e–1

Pediatric uses of devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Pediatric uses of devices

Title 21 Title 21 / Section 379k–1

21 U.S.C. § 379k–1

Electronic format for submissions

Subchapter VII GENERAL AUTHORITY / Part D Information and Education

Electronic format for submissions

Title 21 Title 21 / Section 2251

21 U.S.C. § 2251

Jurisdiction; authorities

Chapter 27 FOOD SAFETY MODERNIZATION / Subchapter IV MISCELLANEOUS PROVISIONS

Jurisdiction; authorities

Title 21 Title 21 / Section 352

21 U.S.C. § 352

Misbranded drugs and devices

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Misbranded drugs and devices

Title 21 Title 21 / Section 353

21 U.S.C. § 353

Exemptions and consideration for certain drugs, devices, and biological products

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Exemptions and consideration for certain drugs, devices, and biological products

Title 21 Title 21 / Section 355

21 U.S.C. § 355

New drugs

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

New drugs

Title 21 Title 21 / Section 360d

21 U.S.C. § 360d

Performance standards

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Performance standards