Tag: pharma

pharma

Washington Focus

Califf Answers Tough Questions, Sets Top Priorities During Senate HELP Hearing

Califf Answers Tough Questions, Sets Top Priorities During Senate HELP Hearing

Dec. 20, 2021 — Dr. Robert Califf, President Joe Biden’s nominee for the FDA Commissioner position, spent roughly two hours answering questions volleyed his way during last week’s Senate Health, Education, Labor, and Pensions (HELP) Committee’s hearing on his nomination. Califf’s answers, peppered with details, facts and figures, references to senators’ home-state concerns, anecdotes about […]

Read more

Regulatory/FDA

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

Sept. 27, 2021 – In the midst of public scrutiny regarding clinical trial transparency, the Food and Drug Administration (FDA) and the United Kingdom’s Health Research Agency (HRA) recently took actions that may indicate their increased willingness to more closely monitor clinical investigators who do not report trial results in a timely manner. “Pharma, researchers, […]

Read more