King & Spalding’s healthcare practice expands
Executive Summary
King & Spalding announced the addition of two senior advisors to its healthcare practice July 24. Beverly Lorell, most recently VP and Chief Medical and Technology Officer at Guidant, will specialize in areas such as clinical trial design, recalls, and pre-marketing materials. Lorell served on FDA's Cardiovascular and Renal Drugs Advisory Committee (1"The Pink Sheet" Jan. 13, 2003, p. 18). Attorney Kay Scanlan, a former consultant for biotech, drug and medical device industries, will specialize in reimbursement. Scanlan previously served in the Office of General Counsel for CMS and as director-reimbursement strategy for Biogen Idec...
You may also be interested in...
Merck Cozaar Will Get Stroke Risk Reduction Claim – FDA’s Temple
Merck Cozaar data from the LIFE study support a risk reduction claim for strokes rather than a broader new indication, FDA Office of Medical Policy Director Robert Temple, MD, said
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.