Californians may have a new privacy initiative on their November 2020 ballot after the California Privacy Rights and Enforcement Act of 2020 (CPREA) was proposed last week. If enacted, this new law would revise and expand upon the California Consumer Privacy Act (CCPA) – which goes into effect in January – by, among other features, creating heightened standards around the use … Continue Reading
As a part of our FDA Series, Reed Smith will be hosting an upcoming webinar, “The changing regulatory landscape of promotion: Drug/biologic advertising in the Trump era and beyond” on Thursday, September 19, 2019 at 2:00 PM ET. This program will discuss promotional enforcement activity under the Trump Administration and how recent technological, demographic, and … Continue Reading
The National Institutes of Health has released a proposed rule designed to provide clarity on the requirements surrounding the submission of information to ClinicalTrials.gov, as mandated by the Food and Drug Administration Amendments Act of 2007. Among these requirements is the submission of summary results for clinical trials involving all pharmaceuticals, medical devices and biological products, regardless of whether they have been approved, licensed or cleared by the Food and Drug Administration. The rule also provides timetable restrictions for the registration of a clinical trial and submission of summary results, as well as guidelines for the reporting of adverse events.… Continue Reading
The Department of Veterans Affairs ("VA") has issued a Notice of Proposed Rulemaking on pharmaceutical sales representatives' access to and activities in VA medical facilities. Drug and Drug-Related Supply Promotion by Pharmaceutical Company Sales Representatives at VA Facilities, 75 Fed. Reg. 24,510 (May 5, 2010).… Continue Reading
Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications. FDA's Center for Drug Evaluation and Research ("CDER") in collaboration with other divisions within FDA, held a two day hearing on November 12th and 13th to help the Agency determine how the statutory provisions, regulations, and policies governing advertising and promotional labeling should be applied to product-related information on the Internet and emerging technologies...… Continue Reading
