On June 27, 2008, the U.S. Drug Enforcement Administration (“DEA”) published a much anticipated Notice of Proposed Rulemaking Regarding Electronic Prescriptions for Controlled Substances. The proposed regulations are in addition to existing prescribing requirements for controlled substances and are expected to work in tandem with …
On June 11, 2008, the Accreditation Council for Continuing Medical Education (“ACCME”) issued for comment a proposal “that the commercial support of continuing medical education end.” The proposal is intended to provoke debate on whether unbiased CME is possible when funded by individual pharmaceutical or …
On June 27, 2008, the District of Columbia Department of Health proposed regulations to implement Title 1 of the SafeRx Amendment Act of 2008 (“SafeRx Act”), which FDA Law Blog previously reported on in January 2008. Under the proposed regulations, pharmaceutical detailers in the District …
Are state law personal injury suits against drug and device manufacturers preempted by federal regulation of these products? This question has been the subject of much litigation since the early 1990s. The U.S. Supreme Court has issued a string of decisions in this area, with one …
