Achieve Compliance: Converting U.S. Prescribing Information (USPI) Labels
The new Pregnancy Lactation Labeling Rule (PLLR) in the U.S. Prescribing Information (USPI) was established to help benefit pregnant women, nursing mothers, and their children by changing the content and format of the information presented in prescription drug labeling in the PLR. Manufacturers must incorporate detailed information on pregnancy and lactation risk summaries (human & animal data), pregnancy exposure registries (if applicable), PK/PD data, pharmacovigilance data, pregnancy testing, contraception and infertility (if applicable). How can the new labeling rules cause pharmaceutical companies to pull their product of the shelf or halt the drug development process? Read to find out!
