April 19, 2021 – Calling the basis for proposed medical device exemptions from premarket notification (510(k)) requirements “flawed,” the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing exemptions for 83 class II devices and one unclassified device which were proposed Jan. 15 in the last few days […]
Read more
Sept. 14, 2020 – As the COVID-19 pandemic persists and the race for a vaccine to prevent contracting the virus heats up, there is a great deal of misinformation circulating about treatments and the majority of Americans are concerned that political pressure from the Trump administration will lead the Food and Drug Administration to approve […]
Read more March 13, 2019 — The Trump administration wasted little time in appointing an acting FDA Commissioner: Dr. Norman (Ned) Sharpless – currently director of the National Cancer Institute – has been tapped to succeed Dr. Scott Gottlieb (who resigned March 5) on a temporary basis. Sharpless is a physician and former director of the Lineberger […]
Read more
April 24, 2017 – There is no doubt that the Trump administration is likely to change health policy, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. If you want predictions and insight from a distinguished panel of FDA and policy experts, […]
Read more