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Documents on Antitrust & Trade Regulation, Health Care, Insurance
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|FDA Continues to Bolster Regulation of Compounding Pharmacies|
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
July 22, 2014, previously published on July 2014Armed 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...
|The Affordable Care Act is Not a Free Pass for Anti-Competitive Mergers|
McDonald Hopkins LLC;
July 18, 2014, previously published on July 9, 2014While 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...
|FDA 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;
July 17, 2014, previously published on June 2014Earlier 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the U.S. Food and Drug Administration (the “FDA”) announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion.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...
|Personalized Medicine Today: PMC Issues Fourth State of the Industry Report|
Antoinette F. Konski; Foley & Lardner LLP;
July 10, 2014, previously published on July 5, 2014Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the understanding and adoption of personalized medicine concepts, services and products,...
|FDA Issues Draft Guidance for Identification and Notification of Suspect Products|
Duane Morris LLP;
July 8, 2014, previously published on June 24, 2014As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." Recently, the U.S. Food and Drug...
|FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers|
Duane Morris LLP;
July 8, 2014, previously published on June 20, 2014The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs:...
|Class Action Rico and Antitrust Suit Filed Against Insurance Industry|
Robert M. Ferm, Kenneth H. Lyman, Lisa F. Mickley, Kevin E. O'Brien; Hall & Evans, L.L.C.;
July 7, 2014, previously published on June 25, 2014A class action lawsuit was filed against the insurance industry in the United States District Court, District of Colorado, on June 21, 2014. The suit names more than 100 insurers writing property policies, as well as trade groups and other trade and business organizations, such as ACORD...
|An Update from the Federal Trade Commission|
Helen J. Kim, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
July 2, 2014, previously published on June 24, 2014The interplay between the Affordable Care Act (ACA), Accountable Care Organizations (ACOs), and antitrust has been a matter of great moment for several years. It has been an issue in litigation such as the Federal Trade Commission’s (FTC) St. Luke’s case. Recently, in a conference,...
|OIG Releases Semiannual Report to Congress Showing Rise in Enforcement Activities|
Scott S. Liebman; Loeb Loeb LLP;
June 9, 2014, previously published on May 29, 2014The Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its Semiannual Report to Congress reporting big enforcement numbers related to its activities during the six-month period from October 1, 2013 to March 31, 2014. The key enforcement figures for the...
|FDA's Fifth Draft Guidance on Biosimilars Sheds New Light on Approval Pathway|
Colleen Heisey, Mark Mansour, Christopher M. Mikson, Stephanie L. Resnik, Emily K. Strunk; Jones Day;
May 30, 2014, previously published on May 2014On May 13, the U.S. Food & Drug Administration ("FDA") issued a draft guidance, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. The draft guidance is intended to assist biological product sponsors with the design and use of clinical...