The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
Considerations for Biopharma Under a First-Inventor-to-File Regime
Gene Grabowski on Pharmaceutical & Medical Devices
Hot Companies in Digital Health
Digital Health: Where is the Action for Entrepreneurs?
The widely publicized start-up company 23andMe, Inc. markets its “personal genome service product” as providing reports on hundreds of diseases and conditions that enable users to “take steps toward mitigating serious...more
In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe...more
The procedure to implant a cardiac stent, which keeps blocked arteries open, includes inserting guidewires to move the device into place. Federal health officials have issued a warning about a defect in some Medtronic...more
As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without...more
In September 2013, the Food and Drug Administration (FDA) issued final guidance regarding its regulation of mobile device medical apps. As expected, it reserved its scrutiny for apps that are truly “medical devices” (because...more
Makers of medical devices marketed pursuant to the Food and Drug Administration’s (FDA) premarket approval process are generally relieved from defending state law failure to warn claims by operation of express preemption, a...more
As we already discussed, 3D printing technologies facilitates the creation of things but also is a great issue for managing traditional IP rights.
This is a technology that will challenge more and more an effective...more
Medical devices and new technologies are becoming more and more linked one to the other in order to allow medical practitioners to continuously monitor their patients’ health conditions through remote monitoring systems...more
Among the hottest topics which will be the subject of discussions at the seminar organized by Confindustria Modena next Monday there are the two proposals for regulations on medical devices and in vitro diagnostic medical...more
On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more
Medical devices are becoming more and more important.
Like pharmaceutical products, they are positioned at the intersection of crucial interests.
Some of these interests are traditionally dealt with by IP...more
Johnson & Johnson manufacturer of DePuy Orthopedics Inc., ASR Hip Implant Products will reportedly propose a $4 billion DePuy hip implant settlement to resolve more than 7,500 lawsuits that have been filed against the company...more
In LifeScan Scotland, Ltd. V. Shasta Technologies, LLC, the Federal Circuit found that LifeScan’s distribution of its One-Touch Ultra glucose meters exhausted its patent rights such that it could not prevent Shasta from...more
In This Issue:
- Biocides Regulation enters into force
- Germany authorised to maintain national limit value on certain chemicals
- Commission proposes to amend the definition of nanomaterials...more
In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more
FDA report demonstrates support for personalized medicine and more efficient regulatory pathways.
In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more
Welcome to the November 2013 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP.
On the anticorruption front, a Swiss tech company’s former exec is charged in the US...more
Seventy-four state and federal physician organizations, including the American Medical Association, recently asked the Centers for Medicare & Medicaid Services (“CMS”) to exclude textbooks and peer-reviewed medical journal...more
In This Issue:
- Top News
..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law
..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues
In the wake of a recent U.S. Department of Health and Human Services Office of Inspector General ("OIG") investigation, physicians with ownership interests in medical device distributorships and hospitals should prepare for...more
On Thursday, October 24, the HHS Office of Inspector General (OIG) released a report responding to a request from members of the Senate Finance Committee to determine the extent to which physician-owned distributorships...more
In This Issue:
A Primer on the Medical Device Excise Tax; FATCA Registration Begins; In re Downey Financial Corp. (U.S. Bankr. Court Dist. of Delaware 10/8/2013); In re NetBank (11th Cir. 9/10/2013); and In re...more
The Centers for Medicare & Medicaid Services (CMS) has initiated a new review process of existing national coverage determinations (NCDs). This new process is designed to retire old policies and may present increased risks to...more
On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI)....more