If approved, the changes would permit both NDA and ANDA holders to unilaterally make safety-related changes.
The standard seeks to reduce injuries and fatalities associated with the use of these products.
Counsel should prepare for and help spur the development of new rules and regulations to clarify the use of these foods.
By C. Matt Alva
An initial impression of the Fennell decision's impact on the national asbestos dockets in St. Clair and Madison Counties.
By Jenny A. Mendelsohn
The Comcast decision may come to be seen as a hollow "victory."
By Jonathan Cohen, Adrian Azer, and John Girgenti
A taste of the key issues companies—and their lawyers—should keep in mind when acquiring such policies.
The ever-changing role of social media has created many new potential legal issues. Listen to longtime litigator Lori Leskin's analysis of recent FDA guidance on the use of social media in the pharmaceutical industry. (12:14 min)
Kristie Wetterer outlines key points to keep in mind upon receipt of a complaint, when crafting an answer, and initial case assessment and discovery. (07:49 min)
Laura J. Walther discusses both offensive and defensive strategies, from a combined legal and media standpoint, to help keep your client's product from having its good name damaged in public. (07:06 min)
Learn about the significance of the Barltett decision and its impact on the court's preemption holdings. (00:57:33)
Young lawyers today face various challenges as they work to further their careers, from establishing and expanding a network to finding a good advocate who will help advance their career. Join us for a discussion on how can young lawyers turn these challenges into opportunities. (01:13:25)
The difference between biologics and small molecule therapeutics—the types of drugs most products lawyers have litigated to date—as well as recent developments stemming from the 2010 Affordable Care Act will be the focus of this roundtable. (56:26)
The YLS monthly call will take place on the first Tuesday of every month at 3 p.m. Eastern time.
The workshop will take place on Thursday, November 14, at Novo Nordisk in Plainsboro, New Jersey.
The November 15th program will include panels on evidence preservation and testing, consumer fraud, social media, alternative billing, and sponsorship.