RA drug development has been slow to revise the trial design paradigm despite agreement on the drawbacks of placebo controls and crossover elements, but FDA biostatistician Levin sees promise in non-inferiority designs.
The US Food and Drug Administration continues to promote the use of active-controlled, non-inferiority trial designs in rheumatoid arthritis, but sponsor uptake has not been enthusiastic, speakers indicated at a recent virtual summit sponsored by the FDA and the American College of Rheumatology.
Rheumatoid arthritis was one of the first indications to benefit from the evolution of the immunology pharmacopoeia from disease-modifying antirheumatic...
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A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order.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.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
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.
