Day: February 23, 2023

Under the drug pricing competition provisions of the US regulations, for the last few years FDA has implemented several programs to encourage multiple manufacturers for each generic drug product. However, these efforts are limited to the finished product manufacturers only and not to the ingredient suppliers. Lack of competition for API manufacturing creates a vulnerability … Read more

The review by IRBs of clinical protocols is a well-recognized measure to assure protection of clinical trial participants all over the world. Per the regulations, IRBs hold a very important place in assuring ethical conduct of clinical trials, and act as surrogates to the FDA for oversight of clinical trial conduct. But are the IRBs … Read more