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20 results 355-2
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Exact match Title 21 Title 21 / Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices / Section 355–2

21 U.S.C. § 355–2

Actions for delays of generic drugs and biosimilar biological products

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Exact citation match for 21 USC § 355-2

Title 21 Title 21 / Section 355–1

21 U.S.C. § 355–1

Risk evaluation and mitigation strategies

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Risk evaluation and mitigation strategies

Title 21 Title 21 / Section 379g

21 U.S.C. § 379g

Definitions

Part C Fees / Subpart 2 fees relating to drugs

Definitions

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 353d

21 U.S.C. § 353d

Process to update labeling for certain generic drugs

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Process to update labeling for certain generic drugs

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 360cc

21 U.S.C. § 360cc

Protection for drugs for rare diseases or conditions

Subchapter V DRUGS AND DEVICES / Part B Drugs for Rare Diseases or Conditions

Protection for drugs for rare diseases or conditions

Title 21 Title 21 / Section 360ff

21 U.S.C. § 360ff

Priority review to encourage treatments for rare pediatric diseases

Subchapter V DRUGS AND DEVICES / Part B Drugs for Rare Diseases or Conditions

Priority review to encourage treatments for rare pediatric diseases

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 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

Authority to assess and use biosimilar biological product fees

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 355c

21 U.S.C. § 355c

Research into pediatric uses for drugs and biological products

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Research into pediatric uses for drugs and biological products

Title 21 Title 21 / Section 360a–2

21 U.S.C. § 360a–2

Susceptibility test interpretive criteria for microorganisms

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Susceptibility test interpretive criteria for microorganisms

Title 21 Title 21 / Section 353a

21 U.S.C. § 353a

Pharmacy compounding

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Pharmacy compounding

Title 21 Title 21 / Section 353b

21 U.S.C. § 353b

Outsourcing facilities

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Outsourcing facilities

Title 21 Title 21 / Section 355g

21 U.S.C. § 355g

Utilizing real world evidence

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Utilizing real world evidence

Title 21 Title 21 / Section 382

21 U.S.C. § 382

Exports of certain unapproved products

Chapter 9 FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VIII IMPORTS AND EXPORTS

Exports of certain unapproved products

Title 21 Title 21 / Section 355f

21 U.S.C. § 355f

Extension of exclusivity period for new qualified infectious disease products

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Extension of exclusivity period for new qualified infectious disease products

Title 21 Title 21 / Section 356a

21 U.S.C. § 356a

Manufacturing changes

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Manufacturing changes

Title 21 Title 21 / Section 356h

21 U.S.C. § 356h

Competitive generic therapies

Subchapter V DRUGS AND DEVICES / Part A Drugs and Devices

Competitive generic therapies