Tag: required
The FDA Proposes New Rule on Unique Medical Device Identification and Marking Requirements
The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
Goals of the … Read More »
Abbott Off-Label Settlement Facts and Figures
The government has made available materials relating to Abbott’s $1.5 billion settlement. (See link below). Here are some quick observations.
Abbott pled guilty to a misdemeanor for “misbranding” its drug Depakote as a result of off-label promotion. Between January 1998 and December 2006, Abbott promoted Depakote to treat behaviors associated with dementia, but FDA had approved the drug only to treat certain types of epileptic seizures and biopolar mania, and to prevent the onset of migraines. (That’s all according to the Plea Agreement and Agreed Statement of Facts filed in court). Abbott has agreed to pay a criminal penalty of $500 million and an additional forfeiture of $198.5 million.
The documents filed in court as part of the plea indicate that the value of the misbranded drugs was $198.5 million (that’s why the forfeiture was for that amount) and that Abbott … Read More »
New FDA Informed Consent Requirements for Applicable Clinical Trials: Practical Approaches for Implementation
For applicable clinical trials regulated by the U.S. Food and Drug Administration (FDA) that are initiated on or after March 7, 2012, sponsors, investigators and institutional review boards will have to assure compliance with an additional informed consent requirement.1 A revision of FDA regulations requires investigators and sponsors of such clinical trials to include the following statement in informed consents:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Website will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
ClinicalTrials.gov is the National Institutes of Health (NIH) website where all “applicable clinical trials” must be registered and trial results posted in accordance with the U.S. Food Drug Administration Amendment Act of 2007 (FDAAA).2 Registration … Read More »