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Book 25:  Laws, Regulations, and Guidance on Pediatric Studies

Book 25: Laws, Regulations, and Guidance on Pediatric Studies

$ 15.95

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This spiral-bound, 5" x 7.5" book is a compilation of various regulatory and guidance documents from the FDA and OHRP on the conduct of research involving children.  It includes the recent revisions from the Food and Drug Administration Amendments Act of 2007 to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), as well as recent guidances on compliance with these Acts and general considerations in the conduct of research on children.

Who Uses this Book?
• Pharmaceutical clinical research staff
• Investigational site staff
• Training personnel
• Regulatory and Legal departments

What's the Price?
• 1-249 copies:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95

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

FDA DOCUMENTS

•  Food and Drug Administration Safety and Innovation Act
    Title V: Pediatric Drugs and Devices
    July 9, 2012

•  Selected Sections of the Food and Drug Administration
    Amendments Act of 2007:
           - Best Pharmaceuticals For Children Act of  2007
           - Pediatric Research Equity Act of 2007

•  Excerpt From The Patient Protection and Affordable Care
     Act Title VII: Improving Access to Innovative Therapies
     Pediatric Studies of Biological Products

•  Code of Federal Regulations, Title 21, Part 50: Protection
     of Human Subjects, Subpart D: Additional Safeguards for
     Children in Investigations (As of April 1, 2015)

•   Code of Federal Regulations, Title 45, Part 46: Protection
    of Human Subjects, Subpart D: Additional Protections for
     Children Involved as Subjects in Research

•   FDA Guidance: Qualifying for Pediatric Exclusivity Under     Section 505A of the Federal Food, Drug, and Cosmetic Act

•   DRAFT FDA Guidance:  How to Comply with the Pediatric
    Research Equity Act (Sept. 2005)

•   FDA Guidance: General Considerations for the Clinical
    Evaluation of Drugs in Infants and Children (Sept. 1977)

•   FDA Guidance: ICH Guideline E-11- Clinical Investigation
    of Medicinal Products in the Pediatric Population
    (Dec. 2000)
    
•   FDA Guidance:  Process for Handling Referrals
    to FDA Under 21 CFR 50.54 - Additional Safeguards for
    Children in Clinical Investigations (Dec. 2006)

•   FDA Guidance:  Nonclinical Evaluation of Pediatric
    Drug Products (Feb. 2006)

OHRP DOCUMENTS
•   Children Involved as Subjects in Research: Guidance
     on the HHS 45 CFR 46.407 ("407") Review Process

•   OHRP Frequently Asked Questions on Research Involving
    Children

•   Protections for Children in Research:  OHRP Report to
    Congress in Accord with Section 1003 of the Children’s
    Health Act of 2000
(May 2001)

 

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