Four proposals that address drug advertising and marketing issues, which have not been widely discussed, may be incorporated into the final health care reform bill. 1) Of most concern to the pharmaceutical industry is a proposal to eliminate the tax deduction for...
Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the...
Starting 15 September 2009, the FDA began enforcing a 15-day limit on post-inspection responses to an FDA-issued form 483 (Inspectional Observations). Upon completion of a facility inspection, the FDA may issue a form 483 to notify an inspected...
The U.S. Food and Drug Administration announced (30 Sept 2009) the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies (REMS), which are required for certain drugs or biologics. The Food and Drug Administration Amendments...
