Michaela, it looks like the rule about drug labelling/pregnancy and lactation is winding through its very final stages right now (May 2014). https://www.federalregister.gov/regulations/0910-AF11/content-and-format-of-labeling-for-human-prescription-drugs-and-biologics-requirements-for-pregnancy . It looks like the Guidance for Industry on Clinical Lactation Trials has not been revised since the 2005 version. -- Liz Brooks, JD, IBCLC, FILCA Wyndmoor, PA, USA *********************************************** Archives: http://community.lsoft.com/archives/LACTNET.html To reach list owners: [log in to unmask] Mail all list management commands to: [log in to unmask] COMMANDS: 1. To temporarily stop your subscription write in the body of an email: set lactnet nomail 2. To start it again: set lactnet mail 3. To unsubscribe: unsubscribe lactnet 4. To get a comprehensive list of rules and directions: get lactnet welcome