Johnson & Johnson will pay $511,000 in fines because imports of pseudoephedrine-containingBenedryl-D to a manufacturing facility in Lititz, Pa., were not reported as required by the Controlled Substances Act, according to an Aug. 5 settlement with the Department of Justice. The U.S. Attorney's Office for the Eastern District of Pennsylvania and J&J subsidiary McNeil-PPC explain the unreported imports of the OTC nasal decongestant tablets occurred during 2001 to 2005, when Pfizer's Warner-Lambert business owned the facility. J&J acquired the facility in 2006 when it bought Pfizer Consumer Healthcare (1"The Tan Sheet" Dec. 18, 2006, p. 9). DOJ says the CSA requires companies to file reports with the Drug Enforcement Agency within 15 days of importing products containing pseudophedrine and other specified chemicals that can be used in manufacturing controlled substances...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
