Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

The FDA has opened the door to the use of Bayesian statistical methods in clinical trials. The worry: Introducing ...

Plasmalogen precursors for Alzheimer’s are named as first program candidate There are nutrients and dietary compounds ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.

Despite the FDA’s CNPV scheme generating high interest, the process around how voucher awards are prioritised remains unclear ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

The FDA’s drug review process can often be "unpredictable," and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce ...