Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

No action taken to withdraw 33 untested drugs from market after one month

“Even though one month has passed since the Parliamentary Standing Committee on Health’s startling revelations that the Drug Controller General of India (DCGI) has approved as much as 33 drugs without clinical trial on Indian patients during the period of January 2008 to October 2010, all the controversial drugs are still in the market with […]

Trade secret changes critical to regulatory sharing, FDA says

“The FDA has said it is critical that trade secret laws are changed to allow it to share manufacturing information with other regulators…more” “Trade secrets include such things as a company’s manufacturing processes and precise product formulations. The Task Force believes that trade secrets have limited value for public disclosure, and that the value for […]

FDA biosimilar guidance permits alternative drug delivery devices

“The FDA has said biosimilars can use different drug delivery devices than their reference products in its long-awaited guidance… more ” According to Wikipedia… “Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator’s […]

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