The dream of tailor-made medication is not a new one, but the prospective cost of such treatments has always been a barrier to growth. Simply put, the return on compounds that only treat small populations cannot justify the investment. With life expectancy...
Although drugs are usually targeted to be selective for a single protein, it is recognized that other proteins may also be affected, a phenomenon called polypharmacology. While off-target interactions can cause potentially harmful side-effects, in some cases, an...
As of 2007, the FDA has the authority to require a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs and biological products, to ensure that the benefits of such products outweighed the risks. Although the FDA mandated risk-management plan applies...
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...
