Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

A New Paradigm for Drug Discovery

“Crowdfunding has revitalized project financing. Science is next. Crowdfunding is the newest innovation in financing, all thanks to the unprecedented access to information through the Internet. Rare Genomics Institute is helping children with rare disease. PetrDish and Microryza are finding funding for research. Community laboratories are opening up to allow amateur scientists to test their […]

FDA Urged to Speed Approval of Drugs

“A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients. The President’s Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster […]

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 […]

Spring 2012 ACS National Exposition

It looks like I’ll be in Europe while this one is going on. This looks like a great Expo. Oh well, next time… San Diego Convention Center Dates: March 25-29, 2012 Location: San Diego, California, USA Theme: Chemistry of Life ACS’ 243rd National Meeting & Exposition will host more than 11,700 presentations on new discoveries […]

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 […]

FDA Finds Significant Violations in Cadila’s production in India

“The FDA has sent a warning letter to Cadila Healthcare’s Ahmedabad, India finished products plant after an inspection found GMP deviations. Inspectors from the US Food and Drug Administration (FDA) visited the plant in January and found significant violations from good manufacturing practices (GMP). Having reviewed Cadila’s response the FDA still has concerns about microbiology […]

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