Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Life Sciences, Biotechnology & Nanotechnology
Arnold & Porter
The General Data Protection Regulation (GDPR) entered into force on 25 May 2018 and, in the absence of any transition period, companies are now expected to be in full compliance with the new requirements.
Jones Day
On May 28 and 29, 2018, the Commission published two studies aimed at examining the economic and legal impacts of the EU's regime on SPCs in particular, as well as on pharmaceutical incentives and rewards in general.
Hogan Lovells
In South Florida and across the country, a growing number of physicians are using wearable medical devices to monitor chronic conditions
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Software as a Medical Device–also referred to as SaMD–is one of the fastest growing innovations in the medical device industry
Jones Day
On April 3, 2018, FDA published long awaited draft guidance entitled " Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials."
Hogan Lovells
The Congressionally Directed Medical Research Program (CDMRP) within the U.S. Army Medical Research and Material Command is a partnership formed by Congress and the military.
Ropes & Gray LLP
The PRC Ministry of Justice recently published a comprehensive draft amendment ("Draft Amendment") outlining the proposed revisions to the current Medical Device Regulations.
Reed Smith
A myth that has regrettably gained some traction lately is that the FDA's clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy.
Seyfarth Shaw LLP
In the first part of this post, we examined the security risks posed by the growing "Internet of Things," especially as connected implants and other medical devices become more common.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The repeal will save laboratories time and money.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
A lot has happened since we last addressed new biosimilar developments in January 2018.
Ropes & Gray LLP
On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling.
Seyfarth Shaw LLP
We all remember the video from a few years ago in which (benevolent) hackers remotely seized control of an SUV, initially playing with the climate control, stereo, and screen but then interfering...
Foley & Lardner
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance ...
Reed Smith
Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today's case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.
Ropes & Gray LLP
In January 2017, the federal departments and agencies that follow the Federal Policy for the Protection of Human Subjects, typically referred to as the Common Rule ...
Arnold & Porter
The advertising of medicinal products in the UK is controlled by a combination of legislation and codes of practice.
Arnold & Porter
While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months ...
Oblon, McClelland, Maier & Neustadt, L.L.P
Three years after a previous legal battle between Sequenom and Ariosa ended in a difficult loss for Sequenom (in what some commentators have characterized as a misapplication ...
Arnold & Porter
On June 12, 2018, the US FDA issued revised, final versions of two guidance documents, "Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities—Questions and Answers"...
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Arnold & Porter
The General Data Protection Regulation (GDPR) entered into force on 25 May 2018 and, in the absence of any transition period, companies are now expected to be in full compliance with the new requirements.
Seyfarth Shaw LLP
In the first part of this post, we examined the security risks posed by the growing "Internet of Things," especially as connected implants and other medical devices become more common.
Oblon, McClelland, Maier & Neustadt, L.L.P
Three years after a previous legal battle between Sequenom and Ariosa ended in a difficult loss for Sequenom (in what some commentators have characterized as a misapplication ...
Jones Day
On May 28 and 29, 2018, the Commission published two studies aimed at examining the economic and legal impacts of the EU's regime on SPCs in particular, as well as on pharmaceutical incentives and rewards in general.
Arnold & Porter
On June 12, 2018, the US FDA issued revised, final versions of two guidance documents, "Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities—Questions and Answers"...
Holland & Knight
On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 18-02 regarding the provision of sample ostomy products...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Software as a Medical Device–also referred to as SaMD–is one of the fastest growing innovations in the medical device industry
Seyfarth Shaw LLP
We all remember the video from a few years ago in which (benevolent) hackers remotely seized control of an SUV, initially playing with the climate control, stereo, and screen but then interfering...
Ropes & Gray LLP
On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device manufacturers' communication of information not contained in product labeling.
Jones Day
Jones Day's Ann Hollenbeck and Courtney Carrell discuss an unexpected False Claims Act action as a private equity firm faces FCA liability.
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