- Did PREA specifically focus on pharmaceuticals; what was the mandate?
- PREA applies to drugs and biological products.
- Is there a list or any scientific research that has the excipients and excipient limits for pediatric formulation?
FDA enables companies to review inactive ingredients that are generally regarded as safe and effective but there is no way to identify excipients by pediatric and non-pediatric use.
There is no list for solid oral dosage forms. There is no regulation that requires that those excipients even be disclosed. Usually, the Agency depends on pharmacology/toxicology reviews and preclinical data. When reviewing an application, FDA chemists will look at specific ingredients and the amount that would be delivered to a child within the age range or weight range of anticipated use.
- What is the age directive for cough and cold remedies?
- The verdict is not out yet. There has been intense discussion with advisory committees and outside experts, but the best age group has yet to be decided. More information needs to be learned about these drugs in children.