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Republican HELP committee members request FDA to step up finalizing biosimilars guidances and transparency
  • McGuireWoods LLP
  • USA
  • May 7 2015

On April 30, 2015, Senators on the Health Education Labor and Pensions Committee (HELP) urged FDA to provide additional guidance on "important issues


Otsuka’s orphan drug exclusivity claims: FDA rips off the band-aid early
  • McGuireWoods LLP
  • USA
  • April 24 2015

Sometimes you need to get in front of the issue earlyOn April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary


Otsuka files amended complaint and motion for tropi for Abilify, pointing to Congressional intent to argue broad exclusivity
  • McGuireWoods LLP
  • USA
  • May 15 2015

As discussed in our April 13, 2015 blog, Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization, Inc., and Otsuka


FDLI’s 2015 Annual Conference educates a record crowd part one of two
  • McGuireWoods LLP
  • USA
  • April 27 2015

On April 20-21, 2015 the Food and Drug Law Institute (FDLI) held its Annual Conference in Washington, D.C., welcoming over 600 heavy hitters from


Weekly Washington healthcare update - January 20, 2015
  • McGuireWoods LLP
  • USA
  • January 20 2015

Upcoming E&C Health Subcommittee Hearing on Permanent SGR FixAdministrator Tavenner to Leave CMS Next MonthCA Exchange Board Implements Adjustments


King v. Burwell: a “straightforward case of statutory construction”?
  • McGuireWoods LLP
  • USA
  • March 5 2015

This is the 47th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health


Weekly Washington healthcare update - March 9, 2015
  • McGuireWoods LLP
  • USA
  • March 9 2015

House Republican Working Group Outlines King v. Burwell “Off-Ramp” Plan... FDA Approves First Biosimilar Product... CMS Approves NH Medicaid Expansion


New compounding guidances and draft FDA-state MOU published by FDA
  • McGuireWoods LLP
  • USA
  • February 18 2015

On February 13, 2015, FDA published four new drug and biological product compounding guidances and a draft memorandum of understanding (MOU) between


ANDA and 505(b)(2) NDA proposed rules: MMA and more
  • McGuireWoods LLP
  • USA
  • February 16 2015

On February 6, 2015, FDA published in the Federal Register a Proposed Rule (PR) entitled: "Abbreviated New Drug Applications and 505(b)(2


Compliance best practices for dental providers - recent OIG activity highlights need for robust compliance efforts
  • McGuireWoods LLP
  • USA
  • December 3 2014

As a result of the actions of a very small minority of the dental industry, dental support organizations (DSOs) have come under increasing