Last week’s blog post by Food and Drug Administration Commissioner Scott Gottlieb, M.D., is providing digital health innovators with a new roadmap to navigate pre- and post-market federal oversight of their products.
The topline for journalists is that in the coming months, the FDA will publish new guidance on digital health products and launch programs to monitor the industry, according to the blog post. Key timeframes and details, culled from Gottlieb’s post: Continue reading →
President Donald Trump has spoken about the cost of drugs frequently. Though not always clearly and consistently, he has called for government negotiation of prices. Drug prices also have caught Congress’s eye, although we’re not quite sure what (if anything) legislators are willing to do about it.
The Food and Drug Administration has banned a communications practice that troubled journalists and sparked protests from AHCJ and others.
The agency has forbidden its media staff from using “close-hold embargoes,” in which reporters receive early access to information provided they promise not to seek comments from others until the embargo lifts, according to a letter sent Thursday to Karl Stark, president of the Association of Health Care Journalists. Continue reading →
The potential benefits of genetic testing are widely touted and drive greater interest in these tests – even though the validity of the science behind such testing remains unclear.
Charles Piller, the West Coast editor for Boston-based online news site Stat, recently reported on the lack of a firm scientific basis for a test that Proove Biosciences in Irvine, Calif., has been marketing as an “opioid risk” detector. Continue reading →
AHCJ is protesting the Food and Drug Administration’s recent restrictive practices in handling news embargoes and has asked the agency for clarification of its policies.
In an Oct. 11 letter to Jason Young, the FDA’s acting assistant commissioner for media affairs, AHCJ President Karl Stark raised strong objections to the practice of providing embargoed information on the condition that reporters refrain from seeking outside comment until the embargo lifts. Continue reading →