FDA has two years of experience with self-registering compounding organizations. Is the agency ready to use them to address situations of access constraints from extreme pricing?
Ex-FDA Deputy Commissioner Josh Sharfstein is suggesting that the agency okay “temporary compounding” as a short-term solution to off-patent products in monopoly situations until FDA can encourage submission of ANDA applications from other companies and give those applications thorough but prioritized (head of the queue) reviews.
Call it the Daraprim policy.
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.
