Code of Federal Regulations, Title 21, Food and Drugs, PT. 1-99, Revised as of April 1, 2015: Buying Time, 1965-1966
Editat de Office of the Federal Register (U.S.)en Limba Engleză Paperback – 17 iun 2015
The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States Federal Government. This official edition of the 21 CFR Parts 0-99 covers a range of topics including general adminsitrative rulings and decisions ....to protection of privacy, environmental impact considerations, pharmaceutical manufacturing practices and reports for devices within the United States and European community; color additives in food, drugs, and cosmetics, and more.
This volume would be appropriate for the general public, plus pharma and start up healthcare manufacturers, as well as food, drug, and cosmetic company personnel interested in developing products to be diseeminated within the United States of America.
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Specificații
ISBN-13: 9780160927973
ISBN-10: 0160927978
Pagini: 513
Dimensiuni: 146 x 232 x 25 mm
Greutate: 0.73 kg
Ediția:Revizuită
Editura: GOVERNMENT PRINTING OFFICE
Colecția Office of the Federal Register
ISBN-10: 0160927978
Pagini: 513
Dimensiuni: 146 x 232 x 25 mm
Greutate: 0.73 kg
Ediția:Revizuită
Editura: GOVERNMENT PRINTING OFFICE
Colecția Office of the Federal Register
Cuprins
Title 21 → Chapter I → Subchapter A
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A—GENERAL
Table of Contents
1.1 to 1.980
GENERAL ENFORCEMENT REGULATIONS
2.5 to 2.125
GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3.1 to 3.10
PRODUCT JURISDICTION
4.1 to 4.4
REGULATION OF COMBINATION PRODUCTS
5.1100 to 5.1110
ORGANIZATION
7.1 to 7.87
ENFORCEMENT POLICY
10.1 to 10.206
ADMINISTRATIVE PRACTICES AND PROCEDURES
11.1 to 11.300
ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12.1 to 12.159
FORMAL EVIDENTIARY PUBLIC HEARING
13.1 to 13.50
PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14.1 to 14.174
PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15.1 to 15.45
PUBLIC HEARING BEFORE THE COMMISSIONER
16.1 to 16.120
REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17.1 to 17.54
CIVIL MONEY PENALTIES HEARINGS
19.1 to 19.55
STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20.1 to 20.120
PUBLIC INFORMATION
21.1 to 21.75
PROTECTION OF PRIVACY
25.1 to 25.60
ENVIRONMENTAL IMPACT CONSIDERATIONS
26.0 to 26.81
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
50.1 to 50.56
PROTECTION OF HUMAN SUBJECTS
54.1 to 54.6
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56.101 to 56.124
INSTITUTIONAL REVIEW BOARDS
58.1 to 58.219
GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
60.1 to 60.46
PATENT TERM RESTORATION
70.3 to 70.55
COLOR ADDITIVES
71.1 to 71.37
COLOR ADDITIVE PETITIONS
73.1 to 73.3129
LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74.101 to 74.3710
LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80.10 to 80.39
COLOR ADDITIVE CERTIFICATION
81.1 to 81.32
GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
82.3 to 82.2707a
LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98
[RESERVED]
99.1 to 99.501
DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
Keywords: medical devices; pharma/pharnaceuutical devices; food and drug companies and manufacturers; medical devic3e3 manufacturers; environmental specialists; 21 cfr parts 1-99; cfr 21 food and drugs 1-99;
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A—GENERAL
Table of Contents
1.1 to 1.980
GENERAL ENFORCEMENT REGULATIONS
2.5 to 2.125
GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3.1 to 3.10
PRODUCT JURISDICTION
4.1 to 4.4
REGULATION OF COMBINATION PRODUCTS
5.1100 to 5.1110
ORGANIZATION
7.1 to 7.87
ENFORCEMENT POLICY
10.1 to 10.206
ADMINISTRATIVE PRACTICES AND PROCEDURES
11.1 to 11.300
ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12.1 to 12.159
FORMAL EVIDENTIARY PUBLIC HEARING
13.1 to 13.50
PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14.1 to 14.174
PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15.1 to 15.45
PUBLIC HEARING BEFORE THE COMMISSIONER
16.1 to 16.120
REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17.1 to 17.54
CIVIL MONEY PENALTIES HEARINGS
19.1 to 19.55
STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20.1 to 20.120
PUBLIC INFORMATION
21.1 to 21.75
PROTECTION OF PRIVACY
25.1 to 25.60
ENVIRONMENTAL IMPACT CONSIDERATIONS
26.0 to 26.81
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
50.1 to 50.56
PROTECTION OF HUMAN SUBJECTS
54.1 to 54.6
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56.101 to 56.124
INSTITUTIONAL REVIEW BOARDS
58.1 to 58.219
GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
60.1 to 60.46
PATENT TERM RESTORATION
70.3 to 70.55
COLOR ADDITIVES
71.1 to 71.37
COLOR ADDITIVE PETITIONS
73.1 to 73.3129
LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74.101 to 74.3710
LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80.10 to 80.39
COLOR ADDITIVE CERTIFICATION
81.1 to 81.32
GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
82.3 to 82.2707a
LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98
[RESERVED]
99.1 to 99.501
DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
Keywords: medical devices; pharma/pharnaceuutical devices; food and drug companies and manufacturers; medical devic3e3 manufacturers; environmental specialists; 21 cfr parts 1-99; cfr 21 food and drugs 1-99;