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The FTC gave generics makers a boost last week in their fight to stop brand drugmakers from using REMS restrictions to block access to sample drugs the generics industry needs to prepare ANDAs. Read More
Federal and state lawmakers are questioning whether the FDA’s Expanded Access program, which allows terminally ill patients to use experimental drugs in certain cases, adequately addresses the current need, with several states considering legislation that would let patients bypass the agency in acquiring investigational therapies. Read More
Each year, up to 20 percent of the U.S. population gets the flu, resulting in more than 200,000 flu-related hospitalizations and 36,000 deaths. Read More
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