Fast Times at FDA: Explaining Accelerated Approval to Ridgemont High s Jeff Spicoli | Arnall Golden Gregory LLP jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.
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On Tap The decision to green-light a controversial Alzheimer’s drug is providing fresh fodder to critics of FDA Acting Commissioner Janet Woodcock. The top Democratic tax-writer in the Senate plans to rewrite his previously bipartisan drug pricing bill to include Medicare price negotiation, a move that would endanger GOP support.
Enforcement in Life Sciences Series:
Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers
About the Enforcement in Life Sciences Series
Recent settlements between the U.S. Department of Justice (DOJ) and a range of FDA-regulated drug and medical device manufacturers provide a snapshot of the DOJ’s enforcement focus. These settlements involve new DOJ theories of liability or new ways of evaluating long-standing industry practices, and may be harbingers of future DOJ enforcement activity. In this six-part series of client alerts, we take an in-depth look at the facts and legal theories in each case or set of cases, discuss what makes each novel, and consider the compliance implications for each.
FDA Letters Suggest Scrutiny Of Virus And Vaping Products law360.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from law360.com Daily Mail and Mail on Sunday newspapers.
(Nature Communications)
People with a previous rheumatoid arthritis diagnosis had a 30% to 50% lower risk of later developing Parkinson s, a nested case-control study showed.
(Journal of Parkinson s Disease)
(Movement Disorders)
(New York Times)
(Alzheimer s and Dementia)
Medicare data showed that payments for neurologist-prescribed brand name drugs jumped 50% from 2013 to 2017, but claims for these drugs rose only 8%. (Neurology)
(JAMA Network Open)
Military veterans with psychogenic or epileptic seizures had higher risks for death by suicide and suicide-related behavior than the general veteran population.
(Neurology Clinical Practice)
Silencing a gene involved in pain signaling reduced pain sensitivity in animal models and reversed chemotherapy-induced chronic pain in mice. (