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Code of Federal Regulations, Title 21, Food and Drugs, Pt. 1-99, Revised as of April 1, 2017

Title:
Code of Federal Regulations, Title 21, Food and Drugs, Pt. 1-99, Revised as of April 1, 2017
Format:
Paperback
USA Price: 
Stock:
In stock
GPO Stock Number:
869-086-00068-1
ISBN:
9780160938092
Description

Title 21 CFR, Parts 1-99, includes rules, regulations, procedures and administrative procedures associated with the Food and Drug Administration and the Department of Health and Human Services (administrative practices, electronic records, public hearings), environmental impact considerations, pharmaceutical good manufacturing practice reports, medical device quality system audit reports/device product evaluation reports (in the United States and European community), protection of human subjects, financial disclosure by clinical investigators, good laboratory practice, patent term restoration, color additives, and more...

 

EST. DELIVERY DATE 07/25/17.

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Table of Contents

Table of Contents:
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
1
1.1 to 1.980
GENERAL ENFORCEMENT REGULATIONS
2
2.5 to 2.125
GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3
3.1 to 3.10
PRODUCT JURISDICTION
4
4.1 to 4.105
REGULATION OF COMBINATION PRODUCTS
5
5.1100 to 5.1110
ORGANIZATION
7
7.1 to 7.87
ENFORCEMENT POLICY
10
10.1 to 10.206
ADMINISTRATIVE PRACTICES AND PROCEDURES
11
11.1 to 11.300
ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12
12.1 to 12.159
FORMAL EVIDENTIARY PUBLIC HEARING
13
13.1 to 13.50
PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14
14.1 to 14.174
PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15
15.1 to 15.45
PUBLIC HEARING BEFORE THE COMMISSIONER
16
16.1 to 16.120
REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17
17.1 to 17.54
CIVIL MONEY PENALTIES HEARINGS
19
19.1 to 19.55
STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20
20.1 to 20.120
PUBLIC INFORMATION
21
21.1 to 21.75
PROTECTION OF PRIVACY
25
25.1 to 25.60
ENVIRONMENTAL IMPACT CONSIDERATIONS
26
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
50.1 to 50.56
PROTECTION OF HUMAN SUBJECTS
54
54.1 to 54.6
FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56
56.101 to 56.124
INSTITUTIONAL REVIEW BOARDS
58
58.1 to 58.219
GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
60
60.1 to 60.46
PATENT TERM RESTORATION
70
70.3 to 70.55
COLOR ADDITIVES
71
71.1 to 71.37
COLOR ADDITIVE PETITIONS
73
73.1 to 73.3129
LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74
74.101 to 74.3710
LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80
80.10 to 80.39
COLOR ADDITIVE CERTIFICATION
81
81.1 to 81.32
GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
82
82.3 to 82.2707a
LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98
[RESERVED]
99
99.1 to 99.501
DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

Audience

Lawyers, law librarians and law students should be familiar with the Code of Federal Regulations.  Law libraries and some academic libraries should have a copy of this publication for their patrons.  In addition, members of government and policymakers, as well as Members of Congress would find this publication useful.

Medical device manufacturers, pharmaceutical manufacturers, physicians, hospital administrators and technicians may be interested in this volume.   Additionally, medical school students and med student interns may also be interested to be updated on the latest regulations relating to pharma and device manufacturers. 

Product Details

Availability Details:
In Stock
USA Price:
$45.00
International Price:
$63.00
Publisher:
National Archives and Records Administration, Office of the Federal Register
Year/Pages:
2017: 594 p.
Weight:
1.4375
Quantity Price:
Discount
Cover:
Paper
Unit of Issue (US):
1
Unit of Issue (Non-US):
1
Item available Date:
04/25/2017
Last Status Update:
12/06/2017
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