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Contract OTC manufacturer Gopers Int. doesn’t have a quality control unit, keep batch records or properly train its employees, according to an FDA Form 483 that features a litany of quality violations. Read More
Ariad Pharmaceuticals failed to submit a slew of adverse event reports within the 15-day deadline and follow the risk evaluation and mitigation strategy for its blockbuster leukemia drug Iclusig, prompting a 483.
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Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for local regulators to tag along on FDA drug manufacturing inspections as observers. Read More
Drug recalls increased for the third straight year, with companies pulling 4 percent more products in 2014 than the previous year and foreign particles being the top culprit. Read More
The FDA has upgraded its rating on Fresenius’ APP Pharmaceuticals’ New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm. Read More
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In a 46-page draft guidance released last month, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality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