Jul 18 - 6:33
RBM is essential in clinical trials, where sponsors monitor clinical investigations and determine any problems or risks involved with their studies that could impact participants or the general public. The FDA wants to...
Jul 15 - 4:47
For two months, Health Canada will open a public consultation on its guidance about promotional ads for health products, such as medical devices and drugs. They want to protect the public by helping to distinguish a...
Jul 10 - 4:34
The U.S. Food and Drug Administration will soon prioritize and review generic emergency opioid overdose treatments, along with any other generic drug submissions that fit under any of their requirements. These...
Jun 28 - 4:44
Health Canada, the Canadian medical regulating authority, announced that new requirements, which was under development since 2018, came into effect this week. The scope of new requirements covers issues related to...
Jun 26 - 4:43
Previously in 2014, the FDA has published a final guidance discussing premarket expectations but the constant technology advancements and changes requires a new guidance. As a result, on October 18, 2018, the FDA...
Jun 25 - 4:28
The US medical device regulating authority, the FDA, terminated the Alternative Summary Reporting Program, used for reporting for over 10 years. Medical device manufacturers exempted from reporting were informed that...
