The uncertainty prevailing over pediatric requirements for medicines in Europe: from new active substance to SPC protection and the MedDRA
This article was originally published in SRA
In the first of a series of articles by Geneviève Michaux on the notoriously complex EU Paediatric Regulation, the Hunton & Williams lawyer focuses on the uncertainty of the legislation with regard to new medicinal products.
You may also be interested in...
TAVR procedure volumes have returned to or exceeded pre-pandemic levels in most locations, Edwards LifeSciences CEO Michael Mussallem said during the company’s 21 October earnings call.
Internal FDA emails obtained by the Environmental Working Group through a FOIA request indicate that the agency was moving toward rulemaking in 2016 to restrict or prohibit use of formaldehyde in heated hair-straightening cosmetics, but seemingly abandoned the initiative. That has Congress, NGOs and other stakeholders asking questions and renewing calls for cosmetics regulatory reform.
Expert outlines how pharma can create resilient and secure supply chains and some benefits of localization.