MASSDEVICE ON CALL — The FDA last week issued final guidance on agency and medical device industry protocol for addressing requests for information and applicable user fees.
Certain requests for classified information, dubbed 513(g) requests, are unilaterally subject to user fees without exception for pediatric devices or for requests from state or federal agencies, according to the guidance.
Swish medical device maker Synthes Inc. and pharmaceutical goliath Eli Lilly & Co. (NYSE:LLY) have partnered to develop a new suite of orthopedic products and osteoporosis treatments.
The companies signed an exclusive worldwide collaboration agreement for development and licensing of early-development products combining Lilly biologics and Synthes biomaterials.
MASSDEVICE ON CALL — Alzheimer’s imaging drug passes FDA panel on certain conditions. A panel of medical experts enlisted by the Food & Drug Administration to review a medical imaging chemical designed to dye the brain plaques related to Alzheimer’s disease passed the drug, but want more information from its developer, Eli Lilly & Co. (NYSE:LLY), reports the Associated Press.
Thermo Fisher Scientific Inc. (NYSE:TMO) inked a five-year supply deal with Eli Lilly & Co. (NYSE:LLY) that will see it take over some of the pharma giant’s clinical trial operations in Indianapolis.
Waltham, Mass.-based Thermo Fisher said its Fisher Clinical Services subsidiary will take over Lilly’s in-house clinical trial materials manufacturing, packaging and labeling operations in the Circle City. That transition should be done some time this summer, and by the end of the year TMO will have taken over the clinical trial materials distribution throughout North America.