A major initiative to reform the EU medicines legislation has hit a bump in the road because of changes required by an internal scrutiny body, but these are likely to be more procedural than policy-related.
The European Commission’s proposal for an overhaul of the EU pharmaceutical legislation is expected to be delayed by a few months after an internal advisory body rejected a document that assesses the likely impact of the proposal.
Although no official announcement has been made, the commission’s Regulatory Scrutiny Board (RSB), which reviews and makes recommendations on draft...
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
