Noven Pharmaceuticals cited for drug patch's faulty release liners
This article was originally published in The Gold Sheet
Executive Summary
FDA issued a warning letter on Jan. 4 to Noven Pharmaceuticals of Miami, Fla, where the firm manufacturers its Daytrana (methylphenidate) patch for attention deficit/hyperactivity disorder. During inspections in June and July 2007, FDA observed a failure to establish scientifically sound and appropriate specifications, standards and test procedure designed to assure that the drug products conform to appropriate standards of identity, strength, quality and purity. For example, a liner release force specification had not been established for the patch at the time of the inspection
You may also be interested in...
California Bill To Age-Restrict Sales Of Diet Pills Further Along Than Other States’ Legislation
CA, MA and NJ legislatures remain in session with bills active proposing regulations similar to NY law effective 22 April requiring retailers, including online, to ask for proof of age when customers buying consumer health products containing ingredients labeled or promoted for weight loss and bodybuilding benefits appear younger than 18.
CRN Has Standing For Steep Hill To Climb Challenging New York's Age-Restricted Sales
Federal judge finds “misreading of the legislation” in CRN’s argument that state “restricts access based purely on what has been said about the product or its ingredients.” But standing to challenge “means that only CRN is positioned right now to go before the court on behalf of industry,” says CEO Steve Mister.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.