EMA
The European Medicines Agency wants to discourage drug companies from submitting marketing applications with very interim data cuts and then expecting they can supplement their application with more data later on by requesting for extended clock-stops.
The European Medicines Agency has given stakeholders until 18 December to give their opinion on its proposed platform for addressing gaps and research needs in regulatory science.
Updated guidance issued by the EU regulator explains how to comply with the provisions of the amended Variations Regulation, which will apply to new submissions from January 2025 and is intended to make lifecycle management “more efficient and future-proof.”
Companies that delay their drug application submissions to the European Medicines Agency by more than 60 days will face an additional fees of €4,200 per delay under a new regulation effective from 2025.
US FDA
Throckmorton is known for enhancing the FDA’s drug shortage work by building bridges between the compliance and quality teams, as well as opioid oversight.
Expected HHS Secretary nominee Robert F. Kennedy Jr.'s dislike of user fees and interest in major FDA reforms could come to a head in the 2027 PDUFA reauthorization.
Pink Sheet reporter and editors, and guest Michael McCaughan of Prevision Policy, continue the discussion of Donald Trump’s potential impact on the FDA, including how Robert F. Kennedy Jr. could change the agency as head of HHS, and FDA Commissioner Robert Califf’s request that industry help preserve the agency status quo.
The FDA’s Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing.