The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” Comments requested by February 9, 2015.
The US Food and Drug Administration published a Final Rule today that sets regulations for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products.
Special Issue: NBDPN CDC order – National Birth Defects Prevention Network
Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD)is soliciting potential new investigators through its development/pilot research project mechanism. Letter of Intent and PI Biosketch due December 1, 2014.
In this issue, Kimmel et al. bring clarity to the question of whether bent long bones, scapulae, and wavy ribs should be considered to be malformations or variations, with an incisive review of the literature.