(DOWNLOAD) "Content and Format of Labeling for Human Prescription Drug and Biological Products - Requirements for Pregnancy and Lactation Labeling (US Food and Drug Administration Regulation) (FDA) (2018 Edition)" by The Law Library * Book PDF Kindle ePub Free
eBook details
- Title: Content and Format of Labeling for Human Prescription Drug and Biological Products - Requirements for Pregnancy and Lactation Labeling (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- Author : The Law Library
- Release Date : January 06, 2018
- Genre: Law,Books,Professional & Technical,
- Pages : * pages
- Size : 367 KB
Description
The Law Library presents the complete text of the Content and Format of Labeling for Human Prescription Drug and Biological Products - Requirements for Pregnancy and Lactation Labeling (US Food and Drug Administration Regulation) (FDA) (2018 Edition).
Updated as of May 29, 2018
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the “Use in Specific Populations” section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the “Labor and delivery” subsection because information about labor and delivery is included in the “Pregnancy” subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.
This ebook contains:
- The complete text of the Content and Format of Labeling for Human Prescription Drug and Biological Products - Requirements for Pregnancy and Lactation Labeling (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure