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Book 16:  Preambles to Good Clinical Practice Regulations

Book 16: Preambles to Good Clinical Practice Regulations

$ 26.95

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A great companion to Book 1, this spiral-bound, 8-1/2" x 11" book is a compilation of preambles to the GCP regulations, 21CFR parts 11, 50, 54, 56, 312 and 314. 

A preamble is the explanatory text that precedes a new or revised regulation when it is published by the federal government.  Preambles provide important background information on a regulation such as:

• The reason(s) for the regulation or change in in the regulation
• The FDA's intent and interpretation of the regulation
• Industry's comments on the proposed regulation
• Reasons for modification of the regulation from its proposed form
   to its final form

Who Uses this Book and How?

Anyone who wants a better understanding of the Good Clinical Practice Regulations.

What's the Price?
• 1-249 copies:  $26.95             • 250-499 copies:  $25.95
• 500-749 copies: $24.95          • 750+ copies:  $23.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

• Preamble to 21 CFR Part 11
• Electronic Records/Signatures (62 FR 13429, March 20, 1997)

• Preambles to 21 CFR Parts 50 and 56
• Informed Consent (46, FR 8942, January 27, 1981)
• Standards for Institutional Review Boards for Clinical
   Investigations (46 FR 8958, January 27, 1981)
• Clinical Investigations Which May Be Reviewed Through Expedited
   Review Procedure Set Forth in FDA Regulations (46 FR 8980,
   January 27, 1981)
• Informed Consent; Standards for Institutional Review Boards for
   Clinical Investigations; Proposed Rule (53, FR 45678, November
   1988)
• Informed Consent; Standards for Institutional Review Boards for
   Clinical Investigations; Final Rule (56 FR 28025, June 18, 1991)
• Informed Consent; Proposed Rule (60 FR 49085,
   September 21, 1995)
• Informed Consent; Proposed Rule (60 FR 66530,
   December 22, 1995)
• Informed Consent, Part II; Final Rule (61 FR 51498,
   October 2, 1996)
• Informed Consent Verification; Final Rule (61 FR 57277,
   November 5, 1996)
• Categories of Research That May Be Reviewed by the Institutional
   Review Board (IRB) Through an Expedited Review Procedure
   (63 FR 60353, November 9, 1998)
• Additional protections for children (66 FR 20589, April 24, 2001)

• Preamble to 21 CFR Parts 54
•  Financial Disclosure by a Clinical Investigator (63 FR 72171,
   December 31, 1998)


• Preambles to 21 CFR Parts 312 and 314
• Proposed New Drug, Antibiotic, and Biologic Drug Product
   Regulations (48 FR 26720, June 9, 1983)
• New Drug and Antibiotic Regulations (50 FR 7452,
   February 22, 1985)
• New Drug, Antibiotic, and Biologic Drug Product Regulations
   (52 FR 8798, March 19, 1987)
• Investigational New Drug Applications and New Drug
   Applications; Proposed Rule (60 FR 46794, September 8, 1995)
• Disqualification of a Clinical Investigator; Proposed Rule
   (61 FR 6177, February 16, 1996)
• Disqualification of a Clinical Investigator; Final Rule (62 FR 46875,
   September 5, 1997)
• Expedited Safety Reporting Requirements for Human Drug and
   Biological Products (62 FR 52237, October 7, 1997)
• Investigational New Drug Applications and New Drug Applications;
   Final Rule (63 FR 6854, February 11, 1998)
• Clinical Hold for products intended for life threatening conditions
   (65 FR 34963, June 1, 2000)

• Expanded Access to Investigational Drugs for Treatment Use
   (74 FR 40900, August 13, 2009)

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