Bipartisan Bill to strengthen testing of pediatric drugs launched in USA
US Representative Mike Rogers (Republican, Michigan) this week introduced bipartisan legislation with Representatives Anna Eshoo (Democrat, California) and Ed Markey
Paediatric safety fears targeted in EMA excipient update
The EMA plans to update its excipient guidelines to cover safety concerns surrounding use in children and pregnant women.
Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)
Patients may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012).
European Medicines Agency gives first positive opinion for paediatric-use marketing authorisation
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given its first positive opinion for a paediatric-use marketing authorisation (PUMA) for Buccolam (midazolam), from ViroPharma SPRL, intended for the treatment of prolonged, acute, convulsive seizures in paediatric patients from the age of 3 months to 18 years.
[EU] EMA: Scientific guideline: Draft guideline on pharmaceutical development of medicines for paediatric use, draft: consultation open
[EU] EMA: Scientific guideline: Draft guideline on pharmaceutical development of medicines for paediatric use, draft: consultation open
Kids’ Liquid Acetaminophen Products to Be StandardizedDrugmakers to Standardize Pediatric Liquid Acetaminophen Product Concentration
Move to Drop Infant Formulation Aims to Minimize Dosing Errors
Ban on phthalates, parabens and alkylphenols
Export and placing on the market for a consideration or free of cosmetic products for infants and children under three containing butylparaben and propylparaben are suspended until the adoption by the French Food Safety Agency health Products, a reasoned opinion to allow new operations
FDA have recently warned about the adverse consequences of propylene glycol as an excipient in oral meds for premature babies.
Propylene glycol is in the HIV combo drug Kaletra (lopinavir/ritonavir) oral solution.
prepared in pharmacies for the special needs of patients