EMEA Updates Application Process for Pediatric Product Plans

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