United States: the new prescription drug packaging insert caused controversy
according to the published experimental procedure (an article in JAMA reported that the FDA's revised prescription drug packaging insert should help doctors understand the relevant pharmacological information, but it may protect drug companies from prosecution due to the simplification of results, which has caused widespread debate.
research shows that the previous warning information has reduced the incidence of adverse drug events leading to redesign, which is the third change made to the insert in nearly a quarter of a century One modification. Dr. Eschenbach, acting Commissioner of FDA, said that the new insert provides basic, concise, readily available and up-to-date information, which is easy to pass on to patients
however, after drug companies found that the modified version made them vulnerable to legal proceedings that could not be guaranteed, FDA tried to exempt them from drug laws, which caused controversy. Therefore, the state legislatures can adopt the advanced DSCC ⑴ all digital closed-loop control system to control and measure the key technologies of manufacturing through the application of intelligent host computers such as IOT, big data and cloud computing. The defense lawyer pointed out that FDA has exceeded its authority and began to pay attention to the extent to which drug companies seem to master the initiative in these events
in a positive record, Dr. denneth shine, executive deputy director of health affairs at the University of Texas, is in favor of the application of the new inserts and will pay attention to how FDA is committed to improving the commercial product manuals prepared for patients
reprinted from: Foreign Pharmaceutical News
LINK
Copyright © 2011 JIN SHI