Skin-Care Claims Before And After FDA Warning Letters

A side-by-side comparison of product claims cited in FDA warning letters and updated claims being used by recipients following their compliance work with the agency. The analysis could provide cues as to promotional language that can be employed without provoking a regulatory response.

There’s no guarantee that skin-care marketers warned by FDA in 2015 for website claims identifying their products as unapproved drugs are compliant now from the agency’s point of view.

However, consistencies can be found in companies’ claims revisions following FDA warnings, some of which have been formally closed out...

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Non-US Approvals - Clone

Devices authorized for marketing outside the US. Data derived from Citeline’s Meddevicetracker. Updated weekly.

Patient access to unapproved medical products allowed under DeFazio, Daschle bills.

 
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PATIENT ACCESS TO UNAPPROVED MEDICAL PRODUCTS WOULD BE ALLOWED under legislation introduced by Rep. Peter DeFazio (D-Ore.) on July 12 and Sen. Tom Daschle (D-S.D.) on July 14. Called the Access to Medical Treatment Act, the legislation would allow health practitioners to administer unapproved drugs, devices, foods or dietary supplements to patients as long as there is no evidence the treatment causes harm and the patient is informed about the treatment and its possible side effects. DeFazio's bill is identified as HR 2019; Daschle's version will be assigned a bill number the week of July 17.

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To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.

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