Tag: medical communications

medical communications

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, […]

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CHC News

Jon Bigelow Is New CHC Executive Director

Jon Bigelow Is New CHC Executive Director

Sept. 17, 2018 – After 16 years with the Coalition for Healthcare Communication, John Kamp will be stepping down as Executive Director and Jon Bigelow has been named his successor. Kamp will continue his association with the Coalition as Washington Counsel. “Jon is exactly the right person at the right time to take the guiding […]

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Regulatory/FDA

Draft Guidance Covers How to Keep Communications Consistent with FDA Labeling

Draft Guidance Covers How to Keep Communications Consistent with FDA Labeling

Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product  manufacturers understand how the agency evaluates product communications, including promotional materials, that present information not contained in the FDA-required labeling but that may be “consistent with” that labeling. “We are aware that firms have questions about how […]

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