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The FDA’s top drug official slammed the current clinical trial system as a major barrier to rapid drug development and urged the drug industry to adopt clinical trial networks as a better way to evaluate new products. Read More
AstraZeneca said the FDA has approved its fish oil-based cardiovascular drug Epanova (omega-3-carboxylic acids) for the treatment of adults with very high triglyceride levels. Read More
A federal appeals court has ruled that generic manufacturers of Merck’s osteoporosis drug Fosamax cannot be held liable for “design defect” claims against the product. Read More
A judge in London’s high court has ruled that local healthcare provider organizations known as Clinical Commissioning Groups (CCGs) cannot choose to ignore UK health guidance simply because they disagree with it. Read More
The FDA is seeking industry feedback on a proposed study to better understand direct-to-consumer advertisements that compare drug pricing, and how that information affects a consumer’s perception of a drug’s overall safety and efficacy versus the comparator product. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More
European drug regulators saw a 30 percent increase in adverse drug reaction (ADR) reporting in the EU following the implementation of massive pharmacovigilance legislation in 2012. Read More
The FDA says there isn’t enough evidence to support marketing aspirin as preventing first-time heart attacks, meaning drugmakers will have to fund more studies if they want to change the agency’s mind. Read More
The FDA has released a proposed rule that would allow it to destroy certain drug imports that have been refused admission into the U.S., the agency’s latest attempt to boost the integrity of the U.S. drug supply chain. Read More