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.
Arnold & Porter
In January 2018, the EMA, as part of its Brexit preparations, launched a survey to gather information from companies on their Brexit preparedness plans, and to identify concerns that may impact public or animal health.
Arnold & Porter
Yesterday, the UK Government finally published its White Paper setting out its position on the UK's continued relationship with the EU post-Brexit.
Reed Smith
Last week, the Judge in the Testosterone Replacement Therapy (TRT) MDL threw out an over $140 million jury verdict.
Duane Morris LLP
Software is eating the biotechnology world. Managers in the traditional biotechnology sector may not be familiar with open source software and related compliance issues, but these issues are bound to come up ...
Morgan Lewis
The US Court of Federal Claims recently interpreted the Trade Agreements Clause applicable to federal government procurements of more than $180,000 as permitting the purchase of domestic end products...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
In a highly anticipated step, which had been teased by agency leadership in their public appearances over the past several months, FDA released a series of draft guidance documents pertaining to the development...
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On April 3, 2018, FDA published long awaited draft guidance entitled " Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials."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.
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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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