Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Oblon, McClelland, Maier & Neustadt, L.L.P
The majority expressed caution about the breadth of its holding, in particular about concerns that the holding could harm the nascent field of personalized medicine.
Akin Gump Strauss Hauer & Feld LLP
In this episode, Akin Gump health care and life sciences counsel Taylor Jones and Matt Wetzel discuss the Justice Department's recent guidance on evaluation of corporate compliance programs.
Morrison & Foerster LLP
We are pleased to announce the launch of the MoFo NDCal IP Resource Center. This complimentary resource is available to the public and provides insights on the judges
Reed Smith
Few things raise our blood pressure as much as the MDL process. MDL stands for Multi-District Litigation, but the M might as well stand for Mutilating and the D for Distorting.
Foley & Lardner
In a non-precedential opinion, the Federal Circuit held as patent-ineligible patent claims to personalized therapy to treat patients who would benefit from inhaled nitric oxide treatment
BakerHostetler
FDA Issues Reminder to Firms Exporting Collagen, Gelatin or Seafood Products – The FDA reminded exporters to the European Union to use the Export Listing Module (ELM) when exporting food products
Hogan Lovells
On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."
Reed Smith
We had been waiting for the Utah Supreme Court's decision in Burningham v. Wright Medical for some time. As we pointed out in a blogpost when Burningham was first certified by the district court
Hogan Lovells
On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests.
Oblon, McClelland, Maier & Neustadt, L.L.P
Claim 25 of Application No. 12/393,833, continued from the '803 application, also recited using random MPS to determine fetal aneuploidy.
Reed Smith
We've blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors
Reed Smith
As your bloggers – at least those without school-aged children – begin to mourn the dawning end of summer, we do at least see one bright spot in the ever-shortening days
Ropes & Gray LLP
Tune in to this discussion to learn more about the expedited review programs and how to secure the benefits.
Hogan Lovells
On 30 August 2019 the U.S. Food and Drug Administration issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals.
BakerHostetler
FDA Will Hold Public Meeting on Food Standards of Identity – The meeting will be held on Sept. 27, 2019, and is intended
Oblon, McClelland, Maier & Neustadt, L.L.P
Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined
Reed Smith
It's not a long decision – but there's still a lot to it. Maybe that's because there wasn't a lot to plaintiff's complaint. Regardless, Sharp v. St. Jude Medical, S.C., Inc., 2019
Mintz
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc.
Ropes & Gray LLP
Third parties serve a critical function to multinational life sciences companies ("MNCs") internationally. MNCs rely on third parties for various functions
Reed Smith
A little knowledge is a dangerous thing. A jack of all trades is a master of none. These cutesy little phrases throw some derision toward one who
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Oblon, McClelland, Maier & Neustadt, L.L.P
Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined
McDermott Will & Emery
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning
Reed Smith
What follows is the second part of our extensive 50-state of cases precluding plaintiffs from proceeding with claims in the absence of admissible expert support. Part One was last week.
Reed Smith
Because we didn't want to split Pennsylvania, this part is a little longer, and part two a little shorter, than average.
BakerHostetler
The 21st Century Cures Act (Cures Act), signed into law on Dec. 13, 2016, was designed to accelerate medical product development and bring new innovations
Ropes & Gray LLP
Third parties serve a critical function to multinational life sciences companies ("MNCs") internationally. MNCs rely on third parties for various functions
Wolf, Greenfield & Sacks, P.C.
Today, companies are developing AI systems to meaningfully analyze the deluge of biomedical data.
BakerHostetler
According to Wikipedia, digital therapeutics can be defined as a treatment or therapy that utilizes digital health technologies to spur changes in patient behavior.
STA Law Firm
Gene editing is a technology and development that has arisen primarily in recent years. It is a topic that is still to this day surrounded by controversy and many ethical question and concerns.
Mintz
On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc.
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