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Book 14:  2021 Selected Recently-Finalized FDA Guidance Documents

Book 14: 2021 Selected Recently-Finalized FDA Guidance Documents

$ 16.95

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Rapidly becoming one of our most popular titles, this spiral-bound, 5" x 7.5" book is a collection of FDA Guidance documents.  It includes those guidances that are most applicable to clinical research staff and includes such topics as:

• Maximum safe starting dose estimates
• Safety assessments prior to drug marketing
• Collecting race/ethnicity data in trials
• Nonclinical evaluation of potential for delayed QT
   interval prolongation by human pharmaceuticals

This book is ideal for clinical research staff involved in developing and reviewing protocols, performing safety assessments, and/or writing clinical study reports.

What's the Price?
• 1-249 copies:  $16.95             • 250-499 copies:  $15.95
• 500-749 copies: $14.95          • 750+ copies:  $13.95

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

• EU Regulation No. 536/2014 on Clinical Trials on Medicinal
  Products for Human Use, and Repealing Directive 2001/20/EC

• Draft FDA GUidance: Electronic Source Data in Clinical Investigations

• FDA Policy for Conducting a Clinical Safety Review of an
  NDA or BLA (FDA Manual of Policies and Procedures,
  MAPP #6010.3, Rev. 1)

• Exception from Informed Consent Requirements for
   Emergency Research

Adverse Event Reporting to IRBs - Improving Human
  Subject Protection

• Exploratory IND Studies

• Estimating the Maximum Safe Starting Dose in Initial
  Clinical Trials for Therapeutics in Adult Healthy Volunteers

• Collection of Race and Ethnicity Data in Clinical Trials

• Nonclinical Evaluation of the Potential for Delayed
  Ventricular Repolarization (QT Interval Prolongation) by
  Human Pharmaceuticals (ICH S7B)

• Premarketing Risk Assessment

• Recommended Approaches to Integration of Genetic
  Toxicology Study Results

• Fast Track Drug Development Programs - Designation,
  Development, and Application Review

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