Dissolution Solutions Network

News, Stories and Commentary from the Pharma Lab

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 […]

31 Drugs Facing FDA Approval in 2012-2013

“Here’s an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012 and into early 2013. This refresh includes changes and additions to the FDA calendar last published at the end of July. ” http://www.thestreet.com/story/11668461/1/31-drugs-facing-fda-approval-in-2012-2013.html

A Total Mess at the FDA?

Derek Lowe, writes for “In the Pipeline”. Check out his investigation of the total mess at the FDA and employee surveillance scandal to brew! Wow, I hope these stories aren’t true. It sounds like a terrible place to work, with many other issues to boot. Top Secret Writers writes “A hugely damning report published by […]

US clears drugs faster than Europe, Canada

“Researchers say the U.S. approved more new medicines in less time than Europe and Canada in the last decade, challenging long-standing criticisms that the Food and Drug Administration lags behind its peers in clearing important new drugs…more“

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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