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FDA Announcement on Guidance for Industry, Generic Drug User Fee Amendments of 2012

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, available here. 

Podcast: What's Next For Obamacare (Part 2)

With President-elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?

Podcast: What's Next For Obamacare (Part 1)

With President-Elect Donald Trump and a new Congress ready to take office in January, the US health care system has reached a pivotal moment. In particular, the overarching question facing the industry and employers across the country is what will become of President Barack Obama's signature legislation, the Affordable Care Act?

Key Issues for the California Cannabis Industry

In the wake of the legalization of cannabis in the state of California following last week’s election, it is important for businesses to take stock of several legal issues as opportunities within this burgeoning market continue to grow. Outlined below are just a few of the areas cannabis businesses in California need to be aware of to avoid legal problems down the road.Real Estate & Land Use

Weeding Through California's Prop 64: Employer Takeaways

This alert was originally published on Law360. 

CMS Published the Covered Outpatient Drug Final Rule

On Monday, CMS issued a notice that, in effect, gives drug manufacturers a three-year reprieve to updating their systems to include sales in US territories in the AMP and Best Price. The government’s release about the changes that were published to Medicaid.gov can be found here.

The GOP's ObamaCare Strategy Pays Off

Arent Fox’s health care counsel Lanhee Chen co-authored an article titled, “The GOP's ObamaCare Strategy Pays Off,” published in The Wall Street Journal. To read this WSJ article, click here. 

What the 2016 Election Means for Health Care

We expect substantial activity on issues related to health care, both in terms of individual medical insurance, entitlement programs such as Medicaid, drug pricing, stimulation of medical innovation, and possibly marijuana reforms.  It is not easy to predict with much certainty what Donald Trump's health care policy would look like now that he has been elected, but his statements and issue papers released by his campaign offer some insight as to his main priorities.   Read the full analysis

Supreme Court Unlikely to Adopt Automatic-Dismissal Rule for Violations of False Claims Act’s Seal Requirement

On November 1, 2016, the Supreme Court heard argument in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby, a False Claims Act case in which the defendant sought dismissal of a qui tam action after the whistleblower violated the FCA’s seal requirement, 31 U.S.C. § 3730(b)(2), and publicly disclosed the complaint. See the oral-argument transcript here.  

CMS Issues Proposed Notice Announcing Changes to NDRA

Today, CMS issued a notice announcing changes that would be made to the Medicaid National Drug Rebate Agreement (NDRA). The government’s release about the changes that were published to Medicaid.gov can be found here: