In the Federal Register (FR) pre-publication page (here) today, FDA announced a proposed study to evaluate patient/consumer ability to understand the impact of Direct to Consumer (DTC) advertising for products with accelerated approvals. These products are typically approved based on a surrogate endpoint (such as a blood test) that has a reasonable likelihood to predict […]
Browsing the daily articles is always fun, whether it is trolling for stories of interest or for something that just makes you want to start banging your head against your keyboard. Today I read an article (here) from the Times of India’s business section. It outlined the number of approvals from Indian-based companies, as […]
So far this FY, total approval actions (note that we are no longer saying approvals) have topped 100 each and every month, from a high of 132 (note that that figure was originally reported as 128, before FDA implemented its revised approval action counting reporting method (see previous post here). While the official April numbers […]
