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Predicate Rules - FDA Regulations

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Includes 20+ Predicate Rules of the FDA.
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Food

 

21CFR106

Infant Formula Quality Control Procedures

 

21CFR107

Infant Formula

 

21CFR110

Current Good Manufacturing Practice in Manufacturing, Packing and Holding Human Food

 

21CFR113

Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

 

21CFR114

Acidified Foods

 

21CFR123

Fish and Fishery Products

 

21CFR129

Bottled Drinking Water

GLP

21CFR58

Good Laboratory Practice for No clinical Laboratory Studies

Drug GMPs

 

21CFR210

Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs

 

21CFR211

Current Good Manufacturing Practice For Finished Pharmaceuticals

GCP

 

21CFR50

Protection of Human Subjects

 

21CFR54

Financial Disclosure of Clinical Investigations

 

21CFR56

Institutional Review Boards – Table of contents

New Drugs

 

21CFR310

New Drugs

 

21CFR312

Investigational New Drug Application

 

21CFR314

Applications for FDA Approval to Market a New Drug
- New Animal Drugs

New Animal Drugs

21CFR510

New Animal Drugs

 

21CFR511

New Animal Drugs For Investigational Use

 

21CFR514

New Animal Drug Applications

Medical Devices

21CFR803

Medical Device Reporting

 

21CFR806

Medical devices – Reports of Corrections and Removals

 

21CFR808

Exemptions from Federal Preemption of State and Local Medical Device Requirements

 

21CFR814

Premarket Approval of Medical Devices

 

21CFR820

Quality System Regulation

Other FDA Regulations

 

21CFR1

Exports: Notification and Recordkeeping Requirements