Book 19: 2024 Preambles to Good Laboratory Practice RegulationsDescription Contents Cover A great companion to Book 9, this spiral bound, 8 1 2" x 11" book is a compilation of preambles to GLP regulations 21CFR part 58. 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

95             • 100-249 copies:  $24

• 1-99 copies:  $26

Electronic Records

of Medicinal Products in the Pediatric Population

• Guidance for Industry: Electronic Source Data in Clinical Investigations

Guidelines of 19 March 2015 on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use

• Institutional Review Boards and the HIPAA Privacy Rule

the new EU Clinical Trials Regulation

The SOM is a source of guidance to laboratories for interpreting the CLIA regulations

for FDA Staff (#7348

How is this Book Used

• IRB Registration Process