www.fdanews.com/articles/124250-emea-updates-application-process-for-pediatric-product-plans
EMEA Updates Application Process for Pediatric Product Plans
February 4, 2010
Drugmakers seeking multiple marketing authorizations
for single products from the European Medicines Agency (EMEA) now can submit one pediatric investigation plan (PIP) to cover them. The EMEA also will hold
presubmission teleconference meetings with applicants that are small, medium-sized or have products to treat pain, according to the updated guidance on PIPs, waivers and modifications.
International Pharmaceutical Regulatory Monitor
International Pharmaceutical Regulatory Monitor