Biopharma FDA Side effects Training 
Clarivate
OCTOBER 19, 2023
Drug candidates have a high rate of failure, as only 10% of de-novo drugs put through clinical trials finally obtain market approval, with the highest rate of attrition occurring at phase I and II of clinical trials (assessing safety, tolerability, dosage, efficacy, and side effects). For example, in the U.S.,
PM360
JUNE 11, 2022
Be clear in your governance documents and training to level set expectations. For example, everyone must be steeped in both FDA and FTC guidelines. Regardless of the tactics and strategies employed, I would encourage more biopharma professionals to get personally involved in patient engagement programs.
Medgadget
FEBRUARY 17, 2023
Interestingly, due to FDA’s regulatory methodology, surgical robots have to be approved for specific indications by the agency. Moreover, the required training to get proficient with the device is only a few hours, unlike two weeks or more for the da Vinci.
Expert insights. Personalized for you.
59 
Let's personalize your content