Oct. 25, 2021 – Translating real-world data (RWD) into a standard format that the Food and Drug Administration (FDA) can process, review and archive will pose challenges that are best met with detailed documentation of a sponsor’s data approach, according to the agency’s draft guidance on data standards for drug and biological products submissions containing […]
Read more Oct. 4, 2021 – As part of its real-world evidence (RWE) program, the Food and Drug Administration last week issued a draft guidance to provide sponsors, researchers and other stakeholders with the agency’s current thinking about the use of electronic health records (EHRs) or medical claims data in clinical studies “to support a regulatory decision […]
Read moreApril 9, 2014 — The Coalition for Healthcare Communication issued the following press release today regarding the CHC Social Media Comment it submitted yesterday on the FDA draft guidance issued in January. FOR IMMEDIATE RELEASE: CONTACT: John Kamp Executive Director Coalition for Healthcare Communication 703-801-4582 (mobile) jkamp@cohealthcom.org CHC Comment on Social Media Draft Guidance Calls […]
Read moreBy John Kamp April 9, 2012 – The only thing really clear about the new guidance on pre-review of the DTC advertising is that advertisers and their marketing agency partners will need to ensure that their FDA submissions include detailed claims substantiation for every ad submitted. Beyond that, the analysis and commentary on the FDA […]
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Although 2011 brings political party shifts in Congress and new challenges, the mission of the Coalition for Healthcare Communication (CHC) remains the same: To protect, for society and individual patients, the benefit of the free flow of healthcare information. This year the CHC will be focusing on four major issues: (1) tax treatment of marketing […]
Read moreCoalition submits formal comment on FDA Draft Guidance on “Presenting Risk Information in Prescription Drug and Medical Device Promotion”. business plan writing service The coalition’s comment, which commends the draft’s many strong points, also criticizes what they believe is the FDA’s over complication of advertising and promotion. Read the full comment
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