GENERAL ENFORCEMENT REGULATIONS

MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

ENFORCEMENT POLICY

GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

PRODUCT JURISDICTION

REGULATION OF COMBINATION PRODUCTS

ORGANIZATION

ADMINISTRATIVE PRACTICES AND PROCEDURES

ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

FORMAL EVIDENTIARY PUBLIC HEARING

PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

CIVIL MONEY PENALTIES HEARINGS

PUBLIC HEARING BEFORE THE COMMISSIONER

REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST

PUBLIC INFORMATION

PROTECTION OF PRIVACY

ENVIRONMENTAL IMPACT CONSIDERATIONS

PROTECTION OF HUMAN SUBJECTS

GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

INSTITUTIONAL REVIEW BOARDS

PATENT TERM RESTORATION

COLOR ADDITIVES

COLOR ADDITIVE PETITIONS

LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

[RESERVED]

DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

COLOR ADDITIVE CERTIFICATION

GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS