What Health Plans Wish the Healthcare Innovation Ecosystem Knew
A California payer lays out the three things she wishes all entrepreneurs knew about how to bring their ideas to market most effectively and initiate successful collaboration.
MedCity Pivot Podcast: A startup co-founder on the urgent changes needed in women’s healthcare
The siloed approach to women's healthcare is one of the main reasons the U.S. is unable to improve its record in this arena, according to Carolyn Witte, co-founder of startup Tia. In our latest episode, she discusses how her company is trying to solve this issue while also working to close the gaps that deepen health inequities in this space.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The year to come in life sciences safety and regulatory practices
The life sciences industry will move toward more agile capabilities for regulatory operations and regulators toward an accelerated approval pathway in support of clinical studies, drawing from lessons learned during the pandemic around global collaboration.
FDA hones activities amid shutdown, but impact on drugmakers appears limited so far
A regulatory consultant said his clients had not experienced any significant disruption, and the agency has been responsive to inquiries.
FDA considering imposing 10-year limit when manufacturers choose older predicates
FDA is modernizing its 510(k) program and one change it is mulling is placing a limit on how old a predicate device is when manufacturers develop a new product showing substantial equivalence.
FDA grants second approval under new expedited-review pilot program
Merck's Keytruda marks the second label expansion, after Novartis' Kisqali, under Real-Time Oncology Review program.
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A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
And the U.S. is already great again from a device perspective
Industry insiders from the medical device world say that FDA has made strides in creating a favorable regulatory environment as Europe gets more stringent leading many companies to decide to introduce products first in the U.S.