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The FDA warned that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in the mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
In a 46-page draft guidance released last month, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
Beginning last month, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. Read More
The average price of generic drugs rose 4.9 percent in 2014, while prices for their branded counterparts jumped 14.8 percent, a new study finds. Read More
Canadian drugmaker Valeant Pharmaceuticals has agreed to pay $296 million to acquire cash-strapped Dendreon’s prostate-cancer drug Provenge and other assets. Read More
A federal court has ruled that any payment from a brand drugmaker to settle a patent infringement case that results in delay of a competitive generic product is enough to support a pay-for-delay claim, lowering the bar for such lawsuits. Read More
The FDA on Thursday approved two fixed-dose combination therapies aimed at lowering viral loads and reducing treatment failure rates in patients with HIV. Read More
The FDA emphasized flexibility in a final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements. Read More
A Japanese active pharmaceutical ingredient manufacturer received a Form 483 for poor validation of its manufacturing methods and supplier controls. Read More