Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon.
Real world evidence is definitely a “hot topic” at FDA.
That phrase was used twice in one week by two different drug review officials from two different divisions in two...
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The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
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.
