The use of the United States FDA programs as a strategy to advance the development of drug products for neglected tropical diseases.

Neglected tropical diseases (NTDs) are infections which are endemic in poor populations in lower- and middle-income countries (LMIC). Approximately one billion people have now or are at risk of getting an NTD and yet less than 5% of research dollars are focused on providing treatments and prevention of these highly debilitating and deadly conditions. The United States Food and Drug Administration (FDA) Orphan Drug Designation program (ODDP) provides orphan status to drugs and biologics, defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and/or disorders that affect fewer than 200 000 people in the United States, or that affect more than 200 000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

Review of the quality of pediatric medications in developing countries.

The quality of essential medicines for pediatric populations in developing countries is largely unknown. This review examines quality studies (2000-2011) of medicines on the WHO Essential Medicine List for Children, the quality of a subset of pediatric formulations, and the association of these poor quality medicines with adverse clinical outcomes. We searched Embase, Medline, BIOSIS, and IPA using MeSH subject terms for quality measures, medicine formulations, and substandard medicines and combined these with 267 medicines, and 91 low-income and lower-middle-income countries.

Do educational materials change knowledge and behaviour about crying and shaken baby syndrome? A randomized controlled trial.

Background: Shaken baby syndrome often occurs after shaking in response to crying bouts. We questioned whether the use of the educational materials from the Period of PURPLE Crying program would change maternal knowledge and behaviour related to shaking.

Methods: We performed a randomized controlled trial in which 1279 mothers received materials from the Period of PURPLE Crying program or control materials during a home visit by a nurse by 2 weeks after the birth of their child.