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The FDA and Customs and Border Protection (CBP) began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
Actavis’ proposed generic version of Novartis’ dementia-treatment Exelon Patch infringes on the product’s patent, a federal judge ruled Thursday in a case that centered on whether a specific chemical ingredient was “obvious” to include in the drug. Read More
Novartis is hoping a federal judge will dismiss a Department of Justice kickback lawsuit against it based on the drugmaker’s argument that the government hasn’t shown a cause-and-effect relationship between the alleged kickbacks to pharmacies and increased sales of its products. Read More
Drugmakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitations that Twitter imposes on each message, the FDA says. Read More
The FDA says drugmakers have no obligation to correct misleading statements or claims made about their products by third-parties on social media, on websites and in online forums – even on websites owned by the drugmaker. Read More
Generic firm Mylan said June 2 that it had reached a settlement with Pfizer to market versions of Celebrex (celecoxib), marking the latest twist in the generic conversion of the blockbuster arthritis pain drug. Read More