Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Reed Smith
We saw recently that Centers for Medicare & Medicaid Services ("CMS") has sent its proposed "Regulation To Require Drug Pricing Transparency" to the Office of Management & Budget ("OMB").
Sharpless Begins as FDA Acting Commissioner – On April 5, Norman E. "Ned" Sharpless, M.D., became the acting commissioner of the FDA. Previously he was the director of the National Cancer Institute.
Holland & Knight
The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential
Akin Gump Strauss Hauer & Feld LLP
On April 2, the U.S. Food and Drug Administration published a long-awaited exploratory white paper proposing a framework for regulating artificial intelligence/machine learning -based software as a medical device.
Smith Gambrell & Russell LLP
Last week, the Georgia legislature passed the Georgia Hemp Farming Act (HB 213), under which farmers may obtain licenses to grow and process hemp.
Reed Smith
Just prior to departing the FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram issued a statement on the Agency's 2019 goals to improve the quality of compounded drugs.
McDermott Will & Emery
Last week the Food & Drug Administration (FDA) made public three new warning letters to Cannabidiol (CBD) and hemp oil product companies sent by FDA and the Federal Trade Commission (FTC).
Reed Smith
No. It can't be. PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) took care of that. Just look at our generic preemption scorecard – the proof is there
Cadwalader, Wickersham & Taft LLP
Will 2019 be the year that federal lawmakers block U.S. law enforcement and regulatory agencies from enforcing marijuana prohibitions in states where marijuana is legal
Wilson Elser Moskowitz Edelman & Dicker LLP
With increased reliance on telemedicine, many physicians question whether the elimination of in-office, face-to-face patient encounters increases their potential medical practice liability risks.
Arnold & Porter
She also discussed how the recent departure of Commissioner Scott Gottlieb from the FDA will impact the consumer products industry.
This week, Congress will continue to look at lowering health costs.
Hogan Lovells
Life sciences' biggest innovations are often developed by young, first-time entrants to the marketplace.
On Feb. 11, 2019, two Department of HHS agencies, the ONC for Health Information Technology and the CMS, released their long-awaited proposed rules designed to further HHS' goal of promoting electronic health...
Departing Food and Drug Administration (FDA) Commissioner Gottlieb reiterated many of the things we have blogged about here ...
It seems like CBD oil is all we talk about, but honestly, it's almost all that our clients are talking about.
Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session.
Reed Smith
That's what we thought when we ran across Restatement §920 recently – it was by accident; we were researching something else.
Hogan Lovells
All companies must be mindful of compliance with Federal Trade Commission (FTC) guidelines for influencers and marketers,
McDermott Will & Emery
The FDA recently issued Guidance announcing its decision to exercise enforcement discretion with regard to the Produce Safety Rule for entities growing, harvesting, packing or holding hops and wine grapes...
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Jones Day
On the heels of the European Union's General Data Protection law, which went into effect in May 2018
Jones Day
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
Butler Snow LLP
Many state legislatures across the country have enacted statutory measures to limit the amount of compensatory and/or punitive damages recoverable ...
Foley Hoag LLP
The symbol at right is one of the three candidate food labeling symbols indicating the presence of "bioengineered foods" being proposed ...
Partners Carl Hittinger and Jeffry Duffy authored an article published by The Legal Intelligencer on July 27, 2018.
Holland & Knight
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2018, published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS).
Cybersecurity threats continued to plague the healthcare sector in 2018. Healthcare organizations notified twice as many individuals under HIPAA and other notification statutes in 2018 as compared with 2017.
Khurana and Khurana
US healthcare giant Amgen has successfully defended two of its patents related to cholesterol-lowering drug Repatha® (evolocumab).
Cooley LLP
That's because, in 2016, the House passed the Fostering Innovation Act of 2015—the very same bill.
Wilson Elser Moskowitz Edelman & Dicker LLP
The cannabis business continues to expand throughout the United States with 33 states that allow some use of medical cannabis, 10 states that allow adult use of cannabis
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