Mondaq USA: Food, Drugs, Healthcare, Life Sciences
McDermott Will & Emery
Earlier this week, US Customs and Border Protection (CBP) issued further guidance on the procedures for importers to take the lower tax rates and credits available under the Craft Beverage...
Holland & Knight
The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates.
Reed Smith
As part of the Trump Administration's fall regulatory agenda, the Department of Health and Human Services (HHS) emphasizes its commitment ...
Reed Smith
You can probably already see where this is going.
Cooley LLP
Consultation with antitrust counsel, both in structuring settlement agreements and in submitting filings, is therefore advisable.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has announced that 1,299 entities have signed agreements to participate in the Administration's new Bundled Payments for Care Improvement (BPCI)...
Foley & Lardner
On November 6, 2018, when Massachusetts voters go to the polls to select a new Governor and other key elected officers
Fenwick & West LLP
​Fenwick securities and corporate finance co-chair Rob Freedman talked to The Wall Street Journal about the life sciences IPO market and what to look for next.
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
Ogletree, Deakins, Nash, Smoak & Stewart
Employers looking for greater transparency on prescription drug pricing and pharmacy benefit manager (PBM) services will soon have a powerful new tool from an unlikely source: California lawmakers.
Reed Smith
In an effort to "modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries," CMS has announced revisions to the local coverage determination (LCD) process.
Duane Morris LLP
It has now been over a month since the pell-mell months of July and August, when we had 13 leases, two options and multiple letters of intent to negotiate, finalize, execute or terminate for various clients ...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
If you read part one of this series, you appreciate that it is imperative that all individuals involved in drug development — including scientific, regulatory, marketing, and financial personnel...
Mintz
Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers?
BakerHostetler
Earlier this month, the Mitre Corporation, on behalf of the Food and Drug Administration (FDA), released the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook...
Seyfarth Shaw LLP
With just under four weeks until Election Day, the push to legalize medical marijuana in Utah continues to progress.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has proposed revising its rules governing the process Medicare beneficiaries, providers, and suppliers.
McDermott Will & Emery
On September 18, 2018, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued TTB Industry Guidance 2018-10, a webpage consisting of questions and answers related to formulas.
Mintz
In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps ...
Mintz
The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the "Blueprint").
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BakerHostetler
Partners Carl Hittinger and Jeffry Duffy authored an article published by The Legal Intelligencer on July 27, 2018.
Foley Hoag LLP
The symbol at right is one of the three candidate food labeling symbols indicating the presence of "bioengineered foods" being proposed ...
Foley Hoag LLP
Earlier this year, the Department of Justice, Civil Division, issued two policy memos that will directly affect its civil enforcement priorities, particularly with regard to healthcare and life sciences companies.
Holland & Knight
On Aug. 9, 2018, Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Medicare Shared Savings Program (MSSP).
Reinhart Boerner Van Deuren s.c.
In 2017, there were at least 477 healthcare data breaches reported to the U.S. Department of Health and Human Services ("HHS") or the media, affecting 5.579 million patient healthcare records.
Mintz
Until a few cases over the last year, courts appeared to be just fine maintaining the paradox that while individuals could lawfully treat their disabilities with licensed medical marijuana use, employers...
Mintz
As in any area of technology, it is important to consider patent protection early in the development of an AI-related invention. However, AI and other digital health inventions raise a number...
BakerHostetler
The World Food Programme (WFP) and UN Women announced last week that they are collaborating in an initiative to use blockchain to aid Syrian refugee women ...
Arnold & Porter
While congressional Republicans safely hold the majority, we anticipate strong efforts to advance their legislative agenda.
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