Informed consent from patients, or institutional review board waivers, are needed to allow bioresearch monitoring inspectors to review source records in a timely fashion without delaying a user fee date, FDA’s Cheryl Grandinetti tells an international good clinical practices workshop.
Sponsors who submit a drug application containing real-world data should ensure that certain measures have been taken ahead of time so that US Food and Drug Administration bioresearch monitoring (BIMO) inspectors can timely review RWD source records without delaying a product’s user fee date.
Prior to data extraction from the RWD source, sponsors should obtain signed informed consent from patients, or institutional review board...
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials, Andrea Manfrin, tells the Pink Sheet what sponsors can expect from the new regulation.
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 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.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
