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FDA Issues Draft Guidance on Bulk Compound Drug Substances
  • FisherBroyles LLP
  • USA
  • March 27 2018

In January of this year, and in response to concerns over the risks associated with the use of non-FDA approved, compounded drugs (particularly in

Anticipating This Year's HIPAA Enforcement Trends
  • Jenner & Block LLP
  • USA
  • February 26 2018

We are a year into a new presidential administration, and yet it seems we are asking the same question that we were at this juncture last year: What

Top 7 Legal Challenges Facing Physicians and Hospitals
  • Jackson Lewis PC
  • USA
  • February 21 2018

The American Health Lawyers Association’s 2018 Physicians and Hospitals Law Institute in New Orleans focused on the legal challenges faced by

New DOJ Guidance Policy Limits Use of Guidance Documents in Federal Civil Actions
  • Sheppard Mullin Richter & Hampton LLP
  • USA
  • February 20 2018

On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the “Brand

Drug Costs Targeted in Administration’s Fiscal Year 2019 Budget
  • Cooley LLP
  • USA
  • February 13 2018

Yesterday, the Administration released its Fiscal Year 2019 (FY19) Budget blueprint. The $4.4 trillion Budget blueprint includes several proposals

Washington Healthcare Update - Feb 5, 2018
  • McGuireWoods LLP
  • USA
  • February 5 2018

The chairman of the House Appropriations Committee, Rodney Frelinghuysen, announced he will retire at the end of his term. The 12-term New Jersey

Washington Healthcare Update - Jan 29, 2018
  • McGuireWoods LLP
  • USA
  • January 29 2018

Republican leaders of the Senate Finance, House Energy & Commerce and House Ways & Means committees sent a letter to the Centers for Medicare and

On the Digital Health Frontier: Developments Driving Industry Change in 2018
  • McDermott Will & Emery
  • USA
  • January 25 2018

As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform
  • Skadden Arps Slate Meagher & Flom LLP
  • USA
  • January 23 2018

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the

FDA finalizes 3D printing guidance
  • Hogan Lovells
  • USA
  • December 20 2017

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its "leapfrog guidance" entitled, "Technical