The FDA established a public docket to get stakeholder comment on the development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics.
Noting the FDA has proposed at least 22 research studies concerning prescription drug advertising and promotion in the past five years, the Pharmaceutical Research and Manufacturers of America (PhRMA) said it is concerned the agency “has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health.”
Reversing a ruling by a lower court in a long-running False Claims Act case, a federal appeals court held that evidence of “just one actual sale” of an allegedly defectively manufactured medical device — together with evidence showing that it was “statistically certain” that the device manufacturers caused third parties to submit “many” false claims to the government — was sufficiently specific to satisfy federal pleading requirements.
The results of a recent poll “clearly illustrate that the current range of variations of date labels” on food products “is problematic for consumers,” according to the Grocery Manufacturers Association (GMA) and the Food Policy Action Network.
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