Searching Content indexed under Media, Telecoms, IT, Entertainment by Joanne Hawana ordered by Published Date Descending.
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FDA's Drug Centers Release New Draft Guidance On Quantitative Info In Consumer-Directed Ads
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps ...
United States
18 Oct 2018
Reexamination Of "Healthy" Continues With An FDA Public Meeting In March 2017
As we've previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim "healthy," in part as result of a dispute with KIND LLC about label claims for its KIND Bar products.
United States
21 Feb 2017
"Multi-Agency Interactive Tool" Available For Developers Of Health Apps
It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies.
United States
14 Apr 2016
Mobile Health Apps Continue To Make Headlines
Recently published studies are illustrating the types of issues that mobile health application, or "app," developers will continue to face as the industry matures alongside an evolving regulatory and enforcement landscape.
United States
29 Mar 2016
Amarin/FDA Settlement: A Significant First Amendment Victory For Off-Label Marketing
The settlement comes after a series of high-profile losses for FDA and the DOJ in the government's attempt to prohibit and criminalize truthful off-label marketing.
United States
16 Mar 2016
Reminder – Truthful Advertising Is Not Optional
We blog frequently about new regulatory developments coming from CPSC or FDA and about enforcement actions brought by those federal agencies as well as state counterparts and private plaintiffs.
United States
15 Feb 2016
First Amendment Protects Truthful Off-Label Speech By Drug Manufacturers
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.'s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency).
United States
18 Aug 2015
FDA Cites Drug Company For Kim Kardashian Endorsement
This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other "celebrity watcher" websites.
United States
13 Aug 2015
FDA Makes More Electronic Submissions Mandatory
In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically.
United States
26 May 2015
FDA Increasing Scrutiny Of Cosmetic Marketing Claims, New Agency Warnings Suggest
Over the past few months, FDA has issued several Warning Letters to personal care companies for making product claims that the agency has interpreted as drug claims.
United States
17 Apr 2015
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