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By Karen Lovitch, Cassandra Paolillo
Last week, a U.S. district court judge in the Southern District of Florida upheld a magistrate judge's decision to dismiss FCA allegations against a compounding pharmacy, its private equity firm owner...
By Michael Renaud, James Wodarski, Sandra Badin, Matthew Galica
As we mentioned in December, the International Trade Commission issued a notice to review the Final Initial Determination and Recommended Determination issued by Administrative Law Judge Pender...
By Kevin Mortimer, Ellen Shapiro
The United States District Court of the District of Connecticut will soon decide whether a putative class member may intervene "for the limited purpose of tolling the statute of repose."
By Patricia Moran
When the Affordable Care Act (ACA) was signed some nine years ago, many employers wondered what would become of COBRA (aka, the continuation coverage requirements of the Consolidated Omnibus
By David Barmak
The Department of Labor (DOL) has issued a Notice of Proposed Rulemaking (NPRM) that it estimates would convert more than one million now overtime-exempt workers to non-exempt, overtime-eligible employees.
By Aaron L. Josephson
In our first two Device Modernization series posts, we discussed FDA's 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts
By Kristen A. Marotta, Sarah Beth S. Kuyers
Regular readers of the blog won't be surprised to hear that there has been another data breach, this time involving a business associate in charge of storing medical records on behalf of health care
By Cynthia Larose, Elana Safner
The Federal Trade Commission ("FTC") has handed down its largest civil penalty ever for violations of the Children's Online Privacy Protection Act ("COPPA").
By Susan Neuberger Weller, Andrew D. Skale, Harold S. Laidlaw
The U.S. Supreme Court held today that bringing a suit for copyright infringement requires that the infringed work actually be registered with the U.S. Copyright Office ...
By Todd Rosenbaum
For an arbitration agreement to be enforceable, the parties must have a reasonable opportunity to understand its terms. See Fagerstrom v. Amazon.com, Inc., 141 F. Supp. 3d 1070 (S.D. Cal. 2015).
By Andrew DeVoogd, Daniel Weinger, Matthew Galica, Christopher Duerden
A recent order from the Northern District of California in AU Optronics Corporation America v. Vista Peak Ventures, LLC, 4:18-cv-04638 (CAND 2019-02-19) ("AU Optronics") ...
By Ellyn Sternfield
Long time readers of our blog may recall that five years ago, I predicted that 2014 might be a game-changing year for the 340B Drug Discount Program.
By Aaron L. Josephson
In our first Device Modernization series post, we discussed how FDA is proposing to modernize the 510(k) review program.
By Eli Greenspan
On Tuesday, executives from seven of the largest pharmaceutical companies testified before the Senate Finance Committee on rising prescription drug prices.
By Cynthia Larose
This month, Mintz's TCPA Digest reviews the Federal Communications Commission's (FCC) adoption of a proposal to extend the Truth in Caller ID rules to calls originating outside the United States ...
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