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Regulatory challenges in interpreting data from multiregional clinical trials have prompted the International Conference on Harmonisation to prepare a guideline on trial planning and design according to a recent concept paper. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy. Read More
Starting next year, FDA manufacturing experts and investigators will participate in premarket reviews of all NDAs, ANDAs and supplements from the earliest stages to identify and address potential manufacturing problems down the line. Read More
Draft FDA guidance on how drugmakers can use social media and web-based forums threatens to prevent the industry from interacting with customers online for fear that companies will be responsible for continuously monitoring any discussions they participate in, drugmakers say. Read More
The FDA said yesterday that Justice Department official Cynthia Schnedar will become director of CDER’s Office of Compliance starting Oct. 6. Read More
Generic drugs continued their market growth last year, rising two percentage points to 86 percent of all prescriptions dispensed in the U.S. market, according to a new study. Read More
An FDA advisory panel is recommending against approval of Actavis’ NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More
The FDA has cleared Takeda and Orexigen Therapeutics’ weight-loss drug Contrave, the first new anti-obesity product to win approval in more than two years. Read More