Mondaq All Regions: Food, Drugs, Healthcare, Life Sciences
Smart & Biggar/Fetherstonhaugh
These provisions will not come into force until October 23, 2018.
Smart & Biggar/Fetherstonhaugh
Eliminate the requirement for filing clinical case reports in a filed submission or supplement, unless requested by the Minister, in order to alleviate administrative burden.
Smart & Biggar/Fetherstonhaugh
We will continue to report updates as further regulations and guidance arise.
Howie, Sacks & Henry
"My brother has a pituitary brain injury" – "I'm sorry, a what?" I hear this phrase often. At 8 years old, my youngest brother was diagnosed with a brain tumor ("craniopharyngioma").
Jones Day
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") ...
Singh & Associates
XLH is a serious disease affecting approximately 3,000 children and 12,000 adults in the United States.
Chetcuti Cauchi Advocates
If there is one certainty about Brexit, it's the uncertainty that it has ushered in across almost all industries in the UK.
Firat Izgi Attorney Partnership
The government aims to make Turkey one of the world's top 10 economies in the field of health services by 2023.
Jones Day
On April 11, 2018, the U.S. Food and Drug Administration ("FDA") permitted marketing of the first device to use artificial intelligence ("AI") autonomously to detect a medical condition.
Reed Smith
When we were on a jury last month we were warned not to consult any outside sources.
Foley & Lardner
Kentucky health care providers and patients will soon enjoy a revamped, and significantly improved, telehealth commercial insurance coverage law.
Drew Eckl & Farnham, LLP
Since at least 1980, federal law has permitted Medicare to recover payments made for medical care provided to beneficiaries when there is liability or workers' compensation insurance...
Singh & Associates
Essure is a permanent birth control procedure that works with your body to create a natural barrier against pregnancy.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On May 9, 2018, FDA issued draft guidance on Uncomplicated Urinary Tract Infections (uUTIs): Developing Drugs for Treatment. The guidance addresses the clinical development of drugs...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
On March 14, 2018, FDA issued draft guidance on Pediatric HIV Infection: Drug Development for Treatment. The draft guidance provides general guidance on the development of drug products ...
Seyfarth Shaw LLP
On November 8, 2016, Maine voters approved "Question 1 – An Act to Legalize Marijuana," and joined a handful of other states, including California, to have legalized the recreational use...
Cooley LLP
The U.S. House of Representatives (House) is slated to vote today on S. 204, a ‘Right to Try' bill passed by the Senate in August 2017.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc.
House Speaker Paul Ryan, R-Wis., last week said congressional leaders are trying to hammer out compromise legislation that would make ...
Day Pitney LLP
Google and Fitbit recently announced plans to integrate Fitbit's user data into electronic medical records (EMRs) using Google's Cloud Healthcare API.
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Norton Rose Fulbright Australia
Businesses in food and agriculture industries should be particularly alive to the risk of slavery in their supply chains.
Holman Webb
Future action for non-compliance with the ACL in the marketing of therapeutic goods may result in much higher penalties.
Stewart McKelvey
The Grievor suffered from osteoarthritis and Crohn's Disease.
Holman Webb
A genomic profile may help a doctor make personalised health decisions, but also raises a number of ethical challenges.
Carroll & O'Dea
The appeal addressed how the trial judge could properly choose between competing expert opinions on mental harm.
Holman Webb
The Appeal decision confirms the need to understand medical malpractice and civil liability policy terms and conditions.
Norton Rose Fulbright Australia
The article considers the responses to some of the key recommendations and potential implications of these responses.
Carroll & O'Dea
This article focuses on some information provision issues addressed in the new ethical guidelines on the use of ART.
Singh & Associates
In the words of advertising tycoon Leo Burnett, "Let's gear our advertising to sell goods but let's recognize also that advertising has a broad social responsibility."
Kochhar & Co.
The Legal Metrology (Packaged Commodities) Rules, 2011 ("Packaging Rules") regulate pre-packaged commodities in India and inter – alia mandate certain labeling requirements prior to sale of such commodities.
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