Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Updates on general safety topics.
Read MoreMAY 3 GIDAC-PEDAC
Atannsoporfin intramuscular injection, by InfaCare Pharmaceutical Corp, for neonates ≥ 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia
Read MoreMAR 23 PEDAC
Safety reviews required by BPCA/PREA
Read MoreMAR 23 PEDAC
Safety reviews required by BPCA/PREA
Read MoreSEP 11-12 PEDAC
1) Use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients 2) Pediatric-focused safety reviews, as mandated by BPCA/PREA/PMDSIA
Read MoreSEP 11-12 PEDAC
1) Use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients 2) Pediatric-focused safety reviews, as mandated by BPCA/PREA/PMDSIA
Read MoreSEP 11-12 PEDAC
1) use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients 2) Pediatric-focused safety reviews, as mandated by BPCA/PREA/PMDSIA
Read MoreMAY 18 PEDAC
Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”
Read MoreMAY 18 PEDAC
Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”
Read MoreMAY 18 PEDAC
Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”
Read MoreMAY 18 PEDAC
Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”
Read MoreMAR 6-7 PEDAC
Safety reviews required by BPCA/PREA/PMDSIA
Read MoreMAR 6-7 PEDAC
Safety reviews required by BPCA/PREA/PMDSIA
Read MoreMAR 6-7 PEDAC
Safety reviews required by BPCA/PREA/PMDSIA
Read MoreSEP 15-16 PEDAC/AADPAC/DSRM
Development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation
Read MoreSEP 15-16 PEDAC/AADPAC/DSRM
Development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation
Read MoreSEP 14 PEDAC
Pediatric-focused safety reviews
Read MoreSEP 14 PEDAC
Pediatric-focused safety reviews
Read MoreAPR 12 PEDAC
Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Information on the 2-day joint meeting of the Pediatric Advisory Committee, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees on September 15 and 16, 2016.
Read MoreAPR 12 PEDAC
Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Information on the 2-day joint meeting of the Pediatric Advisory Committee, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees on September 15 and 16, 2016.
Read More