Archive for April 2016
FDA: Consider Real-World Usage Early On To Avoid Medication Errors
The FDA is pressing drugmakers to build risk assessments into their drug designs early on to cut down on medication errors. Source: Drug Industry Daily
Read MoreSenate Committee Eyes Contempt Proceedings Against Valeant’s Pearson
Two lawmakers are mulling contempt proceedings against outgoing Valeant CEO J. Michael Pearson after he failed to provide a deposition on Friday as part of an investigation into drug pricing. Source: Drug Industry Daily
Read MoreAbbVie, Genentech Scoop Up FDA Approval for Leukemia Drug Venclexta
The FDA has given the green light to the chronic lymphocytic leukemia treatment Venclexta, which will be marketed by AbbVie and Roche’s Genentech unit. Source: Drug Industry Daily
Read MoreKaloBios Announces New Transparency Measures for Drug Prices
Although it has no drugs on the market, KaloBios Pharmaceuticals has announced that it will limit price increases to the rate of inflation or Consumer Price Index, and will do so no more than once a year. Source: Drug Industry Daily
Read MoreFDA Pulls Luveris NDA at Company’s Request
The FDA has withdrawn the NDA for injectable fertility drug Luveris at the request of the manufacturer. Source: Drug Industry Daily
Read MoreReport: Surge in Data Integrity Citations Is Tied to Heightened Risk of Inspections
There is a strong correlation between a surge in warning letters over data integrity issues and increased FDA inspections of manufacturers in India and China — one that could cause production headaches for U.S. drugmakers partnering with these facilities. Source: Drug GMP Report
Read MoreContract Manufacturer Gets Letter Over GMP Concerns, Labeling Issues
A contract manufacturer is being hit with a warning letter over a slew of GMP and labeling violations. Source: Drug GMP Report
Read MoreExpert: Focus on Data Consistency to Streamline Quality, Compliance
The fragmented nature of the modern manufacturing sector necessitates focusing less on technology and more on integration, according to an industry expert. Source: Drug GMP Report
Read MoreFDA Hits Compounders With Letters Over Sterility Issues, Misbranding
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Source: Drug GMP Report
Read MoreQuality Control Fears Prompt Letters to Four Dietary Supplement Makers
Four supplement makers were hit with FDA warning letters March 22 over alleged quality control violations and related issues. Source: Drug GMP Report
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