Mondaq USA: Food, Drugs, Healthcare, Life Sciences
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").
Reed Smith
There was a time when we paid quite a bit of attention to the circumstances under which a participant in a clinical trial could impose liability on the sponsor of the clinical trial.
Womble Bond Dickinson
If an institution doesn't designate which functions are and are not covered by HIPAA, the assumption is that all activities fall under the HIPAA compliance umbrella.
Jones Day
The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to resolve a False Claims Act ("FCA") case for $625 million.
Arnold & Porter
On October 2, 2018, the Food & Drug Administration released revised draft guidance regarding Citizen Petitions and Petitions for Stay of Action under Section 505(q) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Mintz
The Department of Health and Human Services OIG has issued Advisory Opinion No. 18-10 in response to a proposal by a surgical device and wound care product manufacturer to offer its hospital customers...
Cooley LLP
Yesterday, the Department of Health and Human Services ("HHS") through the Centers for Medicare and Medicaid Services ("CMS") ...
Foley Hoag LLP
GFA Federal Credit Union, a Massachusetts credit union with headquarters in Gardner, will become the first financial institution in the Commonwealth to serve the recreational cannabis industry by offering banking services to cannabis companies.
Arnold & Porter
In late September, the US Food and Drug Administration released one draft and two final guidance documents regarding the implementation of the product identifier requirements under the DSCSA, ...
Wilson Elser Moskowitz Edelman & Dicker LLP
U.S. Customs and Border Protection clarified on October 9, 2018, that Canadians who work in Canada's legal cannabis industry may enter the United States for non-work-related reasons without negative consequences.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) is holding a Town Hall Meeting on December 4, 2018 to discuss fiscal year (FY) 2020 applications for add-on payments for new medical services...
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has provided additional guidance on a hospital price transparency policy that goes into effect January 1, 2019.
Gowling WLG
Following months of uncertainty surrounding the way US Border Patrol officers will assess those working in and around Canada's legalized cannabis industry, US Customs and Border Protection (CBP)...
Mintz
Last week concluded the Senate's time in Washington prior to the lame duck session.
Sheppard Mullin Richter & Hampton
In a September 14, 2018 Proclamation, President Donald Trump announced that the week of September 16 through September 22, 2018 would be Prescription Opioid and Heroin Epidemic Awareness Week ("Awareness Week").
Morrison & Foerster LLP
On Friday, October 12, 2018, California's Second Appellate District Court stayed the trial that was set to begin on Monday, October 15, 2018, in Los Angeles Superior Court.
Dickinson Wright PLLC
This is an important update to Dickinson Wright's September 28, 2018 Client Alert styled Canada, Cannabis, and Crossing the Continent: Considerations for Canada-U.S. Companies ...
Frankfurt Kurnit Klein & Selz
The New York Attorney General recently reached a settlement with Pfizer over allegations that the company made false claims ...
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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.
Foley Hoag LLP
The symbol at right is one of the three candidate food labeling symbols indicating the presence of "bioengineered foods" being proposed ...
BakerHostetler
Partners Carl Hittinger and Jeffry Duffy authored an article published by The Legal Intelligencer on July 27, 2018.
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...
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 ...
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...
Arnold & Porter
While congressional Republicans safely hold the majority, we anticipate strong efforts to advance their legislative agenda.
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