Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Singh & Associates
The 19th Annual International Meeting of the Institute of Human Virology was organized from October 23- 26, 2017 at Baltimore, Maryland.
Singh & Associates
A panel of external experts from this committee unanimously voted that the benefits of the therapy, which treats a form of hereditary blindness, outweigh its risks.
McDermott Will & Emery
The regulations are effective January 1, 2018.
Ropes & Gray LLP
Civil actions alleging state-law claims premised on violations of Medicare's rules may turn on specific procedures outlined in the Medicare Act — which contains an express preemption provision — and its implementing regulations.
Reed Smith
This guest post is by Reed Smith‘s Matthew Jacobson. It discusses the FDA's recent guidance on the hot topic of 3D printing as a manufacturing practice for regulated drugs and medical devices...
Much Shelist, P.C.
Beginning on June 1, 2017, providers must use specific forms published on the Centers for Medicare and Medicaid Services (CMS) website in order to utilize the Voluntary Self-Referral Disclosure Protocol (SRDP) ...
Reed Smith
The FDA announced the availability of its guidance entitled "Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff," ...
Holland & Knight
The DOJ elects to proceed (intervene) in only 20 percent to 25 percent of qui tam cases and it does a very good job of separating the wheat from the chaff.
Sheppard Mullin Richter & Hampton
The Republicans are pushing hard to enact a final bill before year end.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D Proposed Rule ...
Sheppard Mullin Richter & Hampton
On December 3, 2017, CVS Health, a giant in the retail pharmacy industry, announced plans to acquire Aetna. Aetna is one of the largest medical insurers in the nation ...
Reed Smith
Plaintiffs also argued that the warnings were inadequate under their various states' laws, but they did not explain why.
Seyfarth Shaw LLP
This article provides a summary of the draft guidance[1] released by the FDA to assist applicants in determining which one of the abbreviated approval pathways ...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Following weekend passage of the Senate tax bill, we return this week with Congress needing to pass a government-spending bill.
Day Pitney LLP
CMS publishes this list of quality and cost measures each year for consideration and works with the National Quality Forum to get input from patients, clinicians, commercial payers and purchasers on the most suitable measures.
BakerHostetler
Congressional Republicans face a Friday deadline to approve a stopgap budget bill to avert a government shutdown
Holland & Knight
In late October, Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) introduced the Medicare Drug Price Negotiation Act of 2017 (S. 2011; H.R. 4138)...
Ropes & Gray LLP
On Oct. 9, 2017, California Gov. Jerry Brown signed into law SB-17, a law intended to foster transparency in connection with drug pricing and its impact on insurance costs.
McDermott Will & Emery
Health-related technology is growing at an accelerating rate, as is its demand.
Proskauer Rose LLP
For the fourth year in a row our London office took part in Tour de Law, a charity event run by Breast Cancer Care.
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Davis Brown Law Firm
Physicians are well-positioned to generate new inventions and thereby improve the treatment of their patients.
Jones Day
The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS")...
Davis Brown Law Firm
In last week's post, we covered initial considerations for physicians considering patent protection
Arnold & Porter Kaye Scholer LLP
The FTC's stated purpose for its workshop was to study the barriers to generic drug competition and whether other market forces create inefficiencies that lead to higher drug prices.
Reed Smith
Talk show host and cannabis mogul Montel Williams recently filed suit against multiple medical marijuana retailers under the Lanham Act and Florida state law for trademark infringement, false advertising, violations of the right to publicity and right to privacy, and unfair business practices.
BakerHostetler
The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump's nominee to be Health & Human Services (HHS) secretary.
Reed Smith
On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care.
Holland & Knight
Under the ACA, insurers may forgo directly reimbursing out-of-network hospitals for emergency care, and instead adjudicate and administer claims directly with individual patients, a district court held earlier this month.
Davis Brown Law Firm
For physicians considering patents, there are some initial issues to address and then a comprehensive patent strategy to develop before going down the path toward filing an application. Once your patent strategy is in place, you can turn your attention to your patent application
Thompson Coburn LLP
The ongoing digitization of the drug and medical device industries continues, and, as a result, new considerations have come to the forefront for companies engaged in clinical trials.
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