Legal updates for: FDA User Fee

by Holland & Knight LLP on 5/22/2013

... the start of the 2013 Florida legislative session, President Gaetz and Speaker Weatherford outlined a joint agenda that included tackling ethics, elections, campaign finance, state pensions and higher education. The Florida House and Senate worked together to pass legislation that made significant reforms to these policy areas, often with strong... more

by McDermott Will & Emery on 5/7/2013

...The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosi... more

by Manatt, Phelps & Phillips, LLP on 4/18/2013

... No Rest for the NAD, As it Decides Multiple Mattress Disputes; Fur Sure? Retailers Make Faux Faux Fur Claims; Got Settlement? Muscle Milk Suit Settles for $5.3 Million; TCPA Class Actions Prohibited in New York; Employer Violated Privacy, Publicity Rights by “Hijacking” LinkedIn Account; and Noted and Quoted . . . Adweek and... more

by Patton Boggs LLP on 4/15/2013

... 10th, President Obama submitted his FY 2014 Budget Proposal to Congress. In the normal course of events, the President would have unveiled his spending plan in early February as required by law. But, as with all fiscal matters in Washington, D.C. these days, reality has not followed a “normal” course of events. Instead, the... more

by Patton Boggs LLP on 4/10/2013

... On Friday, April 12, the House Appropriations Subcommittee on Agriculture, Rural Development and FDA will hold a hearing on the “FY 2014 Appropriations: Agriculture, Rural, FDA.” ... more

by McDermott Will & Emery on 3/29/2013

... Court - Supreme Court Finds That “First Sale” Doctrine Applies to Works Patents - Joint Actors as It Relates to Method Claim Infringement; Federal Circuit Ruling Clears Way for Approval of Generic Version of Fentora; Federal Circuit Affirms Injunction Against Impax Labs and Bars Generic Introduction; Federal... more

by Cozen O'Connor on 3/14/2013

...would fund the government through the end of the fiscal year.  The measure allows the Food and Drug Administration (FDA) to fully collect medical device and generic drug user fees.  Senator Ted Cruz (R-Texas) is planning to offer an am... more

by Polsinelli on 3/7/2013

... Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ..Payment or Other Transfers of Value ..Ownership or Investment Interest - Payment and Other Transfer of Value Report Content Reports ... more