Was the REMS meant to regulate prescribers and pharmacists?

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...

Precedent-setting Lawsuit: Free Speech vs. Off-Label Drug Promotion

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...

Enforced 15-day limit on FDA form 483 responses

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...