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HTMLSham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?
Robert L. Magielnicki; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 19, 2014, previously published on August 12, 2014
Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may harm competition or competitors. The Supreme Court has...

 

HTMLFDA to focus on Laboratory Developed Tests
McDonald Hopkins LLC;
Legal Alert/Article
August 19, 2014, previously published on August 13, 2014
The Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 of its intent to issue draft guidance regarding regulatory oversight of laboratory developed tests (LDTs), including reporting and premarket submission requirements. The FDA treats LDTs as a subset of in vitro...

 

HTMLNo Bones About It: Tenth Circuit Permits Narrowest Market Definition and Raises the Bar for an Entry Defense When Reinstating Monopolization Suit
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 15, 2014, previously published on August 11, 2014
On August 5, 2014, the Tenth Circuit Court of Appeals reinstated claims of monopolization and attempted monopolization under Section 2 of the Sherman Act brought by a manufacturer of surgical bone mills against a competitor. In reversing the district court's grant of summary judgment for the...

 

Adobe PDFMost Favored Nation Clauses: Do they Limit Free Competition or are they Pro Competitive?
Claudio Lizana, Lorena Pavic; Carey;
Legal Alert/Article
August 15, 2014
Recently, the U.S. Department of Justice ("DOJ") began reviewing a number of contracts which it calls "contracts that reference rivals". One type of such contracts is those containing Most Favored Nation Clauses ("MFN Clauses").

 

HTMLFDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
August 5, 2014, previously published on August 4, 2014
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that certain tests used by health care professionals that diagnose and treat...

 

HTMLFDA Accepts First Application for Biosimilar Product
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be the first biosimilar product to enter the U.S. market under the nearly five-year-old Biologics Price Competition and Innovation Act...

 

HTMLUSAA Wins Putative Class Action Suit Based Total Loss Valuations and the Filing of Owner-Retainted Reports
Martin Disiere Jefferson Wisdom L.L.P.;
Legal Alert/Article
August 4, 2014, previously published on July 28, 2014
Sunny Letot, a well-known Dallas judicial campaign consultant and descendant of a notable North Texas pioneering family, was involved in a rear end collision with an insured of USAA. She filed suit against the insured driver for negligence and then joined the carrier on multiple novel theories...

 

HTMLFDA Continues to Bolster Regulation of Compounding Pharmacies
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of...

 

HTMLThe Affordable Care Act is Not a Free Pass for Anti-Competitive Mergers
McDonald Hopkins LLC;
Legal Alert/Article
July 18, 2014, previously published on July 9, 2014
While the Affordable Care Act (ACA) incentivizes mergers of hospitals, physician groups, and other providers and facilities, the FTC is scrutinizing mergers that would leave few local healthcare options for patients seeking care close to home in an effort to ensure competition is preserved and...

 

Adobe PDFFDA Promises Guidance on Lawful Off-Label Promotion
Michael F. Buchanan, William F. Cavanaugh, Joshua A. Goldberg, Erik Haas, Daniel S. Ruzumna; Patterson Belknap Webb & Tyler LLP;
Legal Alert/Article
July 17, 2014, previously published on June 2014
Earlier this month, the U.S. Food and Drug Administration (the “FDA”) announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The healthcare industry has heralded this announcement as a...

 


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