EMEA issues its first opinions on PIPs; six waivers adopted, may review process
The European Medicines Agency's (EMEA) Pediatric Committee (PDCO) adopted its first opinions on pediatric investigation plans. A PIP sets out a program for the development of a drug in the pediatric population, which aims to generate the necessary quality, safety and efficacy data through studies in children to support the authorization of the product for use in this population.
The opinions on PIPs adopted by the PDCO relate to the following drugs:
- L-asparaginase, from medac Gesellschaft fuer Klinische Spezialpraeparate mbH, an oncology product; and
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