Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Arnold & Porter Kaye Scholer LLP
Demand for greater transparency and disclosure of pre-clinical and clinical data by industry continues to attract significant debate.
Miles & Stockbridge
The IEC 62304 standard [1] specifies life cycle requirements for the development of medical software and software within medical devices.
Morrison & Foerster LLP
As previously reported, the U.S. markets have experienced a 35% year-over-year increase in volume, with 111 IPOs completed in the first nine months of 2017, raising $26.5 billion.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
In Amgen Inc. v. Sanofi, No. 2017-1480, the Federal Circuit reversed and remanded for a new trial because the district court (1) incorrectly excluded post-priority-date evidence regarding...
Ropes & Gray LLP
What should we expect from the U.S. Securities and Exchange Commission regarding the status of new and existing initiatives by Congress and SEC policy, and how will it affect disclosure...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow.
Stoll Keenon Ogden PLLC
After an international dressage horse turns up with a false positive this contagious disease, the USDA testing protocol comes under fire.
Morgan Lewis
The US Court of Appeals for the Federal Circuit issued its opinion on October 5 in Amgen Inc. v. Sanofi, Case No. 2017-1480...
Arnold & Porter Kaye Scholer LLP
Human factors are increasingly being recognised as an important element of medical devices, in particularly in relation to managing patient safety.
Mayer Brown
Subject to certain limitations, investors can choose between providing debt and equity funding to a start-up company
Jones Day
The TMB recently released proposed rules to implement Senate Bill 1107, which became law in May 2017 and allows for physician-patient relationships to be created solely through the provision of telemedicine services.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The U.S. Department of Veterans Affairs ("VA") is taking a significant step towards expanding needed services to Veterans by proposing a rule to preempt state restrictions on telehealth.
Reed Smith
Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into patient care.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app.
Ropes & Gray LLP
In the world of fee-for-service health care, most medical devices were sold to hospitals or other health care providers for use in the diagnosis or treatment of patients.
Horne LLP
If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26 security advisory from the company.
Dentons
Together with new guidance regarding the potential regulatory pathways for gene therapies, the FDA announced on Monday, August 28, 2017...
Foley Hoag LLP
The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation ("the GDPR") will apply in all Member States of the European Union ("EU") and will replace...
Foley Hoag LLP
This is the third post in a three-part series designed to provide a summary of some of the GDPR features that are likely to have the most substantial impact on healthcare/life science related businesses.
Arnold & Porter Kaye Scholer LLP
In a recent article published in Intellectual Property & Technology Law Journal, and expanding on our previous post, we discuss the legal and regulatory implications of applying AI to the EU and US healthcare...
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Ropes & Gray LLP
In the world of fee-for-service health care, most medical devices were sold to hospitals or other health care providers for use in the diagnosis or treatment of patients.
Arnold & Porter Kaye Scholer LLP
In a recent article published in Intellectual Property & Technology Law Journal, and expanding on our previous post, we discuss the legal and regulatory implications of applying AI to the EU and US healthcare...
Arnold & Porter Kaye Scholer LLP
Demand for greater transparency and disclosure of pre-clinical and clinical data by industry continues to attract significant debate.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app.
Mayer Brown
Subject to certain limitations, investors can choose between providing debt and equity funding to a start-up company
Reed Smith
Reed Smith is at the forefront of thought leadership surrounding 3D printing and how this revolutionary technology will impact our pharmaceutical and medical device clients, as well as universities and other leading medical centers which are incorporating this technology into patient care.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The U.S. Department of Veterans Affairs ("VA") is taking a significant step towards expanding needed services to Veterans by proposing a rule to preempt state restrictions on telehealth.
Jones Day
The TMB recently released proposed rules to implement Senate Bill 1107, which became law in May 2017 and allows for physician-patient relationships to be created solely through the provision of telemedicine services.
Arnold & Porter Kaye Scholer LLP
Human factors are increasingly being recognised as an important element of medical devices, in particularly in relation to managing patient safety.
Foley Hoag LLP
The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation ("the GDPR") will apply in all Member States of the European Union ("EU") and will replace...
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