Background Analysis: US FDA Advisory Committee to Review Sedation in Pediatric Clinical Trials and Drugs Required for Review Under BPCA/PREA/PMDSIA – MAR 23-24, 2015 (PEDAC)
The US FDA has scheduled a Pediatric Advisory Committee (PEDAC) Meeting for Monday to Tuesday, March 23-24, 2015.
On Monday, March 23, 2015, the Subcommittee of the PEDAC will discuss the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations, at 21 CFR 50 subpart D. A short presentation about the subcommittee's discussion will then be presented to the PEDAC on Tuesday, March 24, 2015.
On Tuesday, March 24, 2015, the PEDAC will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA, Pub. L. 107-109), the Pediatric Research Equity Act (PREA, Pub. L. 108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (PMDSIA). The PEDAC will discuss the following products: CYMBALTA (duloxetine hydrochloride), QUILLIVANT XR (methylphenidate hydrochloride), LUNESTA (eszopiclone), RISPERDAL (risperidone), OXTELLAR XR (oxcarbazepine), REVATIO (sildenafil), ADVAIR HFA (fluticasone propionate/salmeterol xinafoate), DYMISTA (azelastine hydrochloride/fluticasone propionate), QNASL (beclomethasone dipropionate), VENOFER (iron sucrose), INVIRASE (saquinavir), ALTABAX Ointment (retapamulin), FluMist QUADRIVALENT (influenza vaccine live, intranasal), FLUARIX QUADRIVALENT (influenza virus vaccine), Medtronic ACTIVA DYSTONIA THERAPY, and LIPOSORBER LA-15 System.