EMA
Scientific advances in pharmacogenomics have prompted the European Medicines Agency to propose revisions to its existing guideline to ensure its continued relevance and applicability.
The standard baseline of regulatory data protection will remain at eight years under the new pharma package, while market protection will drop to a year as standard. However, innovative products that fulfil certain criteria could get up to 11 years of market exclusivity.
The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.
A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.
US FDA
Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.
Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.
As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.
At an expert panel overwhelmingly composed of people favoring expanded testosterone use and loosened safety warnings, career FDA staff suggested new clinical trials would be required to approve some of the changes.