The Best Pharmaceuticals for Children Act (BPCA) became law in 2002. It was reauthorized in 2007 under the Food and Drug Administration (FDA) Amendments Act, in 2012 under the FDA Safety and Innovation Act, and again in 2017 under the FDA Reauthorization Act.

The overarching goals of the BPCA are:

• To encourage the pharmaceutical industry to perform pediatric studies to improve labeling for patented drug products used in children, by granting an additional 6 months patent exclusivity
• For NIH to prioritize therapeutic areas and sponsor clinical trials and other research for off-patent drug products that need further study in children

Contents

• Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Levetiracetam
  Christoph P Hornik, Kanecia Zimmerman, Anil Maharaj, and Stephen J Balevic. Ravinder Anand and Lily Chen.
  Bethesda (MD): National Institute of Child Health and Human Development (US); January 21, 2022.
• Safety and Efficacy of Caffeine Citrate in Premature Infants
  IND Sponsor and Principal Investigator: P. Brian Smith; Ravinder Anand and Elizabeth H Payne.
  Bethesda (MD): National Institute of Child Health and Human Development (US); March 14, 2018.
• An Open Label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants
  Principal Investigators: P. Brian Smith and Danny Benjamin. Report Written by: The Emmes Corporation (BPCA DCC).
  Bethesda (MD): National Institute of Child Health and Human Development (US); April 6, 2017.
• Safety and Efficacy of High-Dose Acyclovir in Infants with HSV or Suspected HSV
  P. Brian Smith; Ravinder Anand and Karen Martz.
  Bethesda (MD): National Institute of Child Health and Human Development (US); April 6, 2017.
• Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Doxycycline
  Chiara Melloni; Michael Cohen-Wolkowiez; Ravinder Anand and Elizabeth H. Payne. Danny K. Benjamin.
  Bethesda (MD): National Institute of Child Health and Human Development (US); January 11, 2017.
• A Randomized, Double-Blind, Placebo Controlled Study of the Efficacy of Lithium for the Treatment of Pediatric Mania Followed by an Open Label Long-Term Safety Period, Double-Blind, Placebo-Controlled Discontinuation Phase, and Open Label Restabilization Period (COLT2)
  Robert Findling, Principal Investigator; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Study Sponsor; Perdita Taylor-Zapata, Sponsor Contact Person; Ravinder Anand and Karen Martz.
  Bethesda (MD): National Institute of Child Health and Human Development (US); December 1, 2015.
• Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥ 85th Percentile
  P. Brian Smith, Michael J. Smith, Daniel Gonzalez, Michael Cohen-Wolkowiez, Ravinder Anand, and Karen Martz.
  Bethesda (MD): National Institute of Child Health and Human Development (US); October 15, 2015.
• Use of Lorazepam for the Treatment of Pediatric Status Epilepticus: A Randomized, Double-Blinded Trial of Lorazepam and Diazepam
  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sponsor; George Giacoia, Sponsor Contact Person, James Chamberlain, Edmund V. Capparelli, Daniel Gonzales, and Jeffrey Guptill. Ravinder Anand, Karen Martz, and Traci Clemons.
  Bethesda (MD): National Institute of Child Health and Human Development (US); September 15, 2015.
• Ampicillin Pharmacokinetics and Safety in Infants
  Daniel K Benjamin, Jr., IND Sponsor; Report Written by: Andrew Lewandowski and Ravinder Anand.
  Bethesda (MD): National Institute of Child Health and Human Development (US); November 24, 2014.
• A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects
  Eunice Kennedy Shriver National Institute of Child Health and Human Development, Study Sponsor; Gregory Hammer, Scott Schulman, and David Drover. Ravinder Anand and Andrew Lewandowski.
  Bethesda (MD): National Institute of Child Health and Human Development (US); February 1, 2012.
• Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 days) with Suspected or Complicated Intra-abdominal Infections
  Danny Benjamin, P. Brian Smith, Edmund V. Capparelli, and Michael Cohen-Wolkowiez. Ravinder Anand and Karen Martz.
  Bethesda (MD): National Institute of Child Health and Human Development (US); July 15, 2011.