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A pharmacist advocate is urging manufacturers to provide more information on the reason for and expected duration of a drug shortage, so that healthcare providers can better plan for how the shortage will affect patient care. Read More
Indian regulators are reminding drug investigators seeking approval for clinical trials that they must submit information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product to existing options. Read More
The FDA has withdrawn three holdout ANDAs for products containing the narcotic propoxyphene due to safety issues, but the drugs have likely long since been discontinued, the agency said. Read More
Astellas Pharma and Medivation won a new indication for their joint cancer therapy Xtandi, allowing the drug to be given to a wider swath of men with metastatic castration-resistant prostate cancer. Read More
A federal judge has denied a motion by Merck to dismiss two lawsuits involving its mumps vaccine, one by whistleblowers alleging the company presented misleading efficacy data on the vaccine, and another by direct purchasers who contend the company created a monopoly on the product. 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