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Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when ...
The new rules come as Donald Trump's advisers begin floating plans for the FDA and the pharmaceutical industry. Robert F. Kennedy Jr., an anti-vaccine activist who has advised the president-elect, wants to eliminate TV drug ads. He and other industry critics point out that the U.S. and New Zealand are the only countries where prescription drugs ...
The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising. In 2022, the Act was updated with the FDA Modernization Act 2.0, which cancelled a 1938 mandate to require animal testing for every drug development protocol.
The FDA also recognized reminder ads (such as the aforementioned Claritin ad) as not being subject to these rules, since they do not contain claims or statements regarding the indications and benefits of the medication. [7] [8] The industry quickly took advantage of the new guidelines: by 1998, advertising spending on DTCA had reached $1.12 ...
At a time when most other industries are spending less on television advertising, drug companies are spending more. They are also devising new forms of so-called direct-to-consumer outreach, like smartphone apps that consumers may not even realize are a form of marketing and that the FDA is still figuring out how to regulate.
It also talks about the FDA citizen petition. The 1100 series includes updated rules deeming items that statutorily come under the definition of "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. The items affected include E-cigarettes, Hookah tobacco, and pipe tobacco. [5]
It requires the FDA to establish an Office of the Chief Scientist to: (1) oversee, coordinate, and ensure quality and regulatory focus of FDA intramural research programs; (2) track and coordinate intramural research awards made by each FDA center or science-based office; (3) develop and advocate for a budget to support intramural research; (4 ...
The FDA's statement follows a major shortage of baby formula earlier this year due to a shutdown at Abbott's plant in Michigan after complaints of infection by a bacteria called cronobacter sakazakii.