Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Barnes & Thornburg
The FDA recently issued a final guidance titled "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations."
Jones Day
In a follow-up to a final rule issued in September 2013 FDA has issued a small entity compliance guidance on the Unique Device Identification System.
Jones Day
FDA announced the availability of the action plan required by Section 907 of the Food and Drug Safety and Innovation Act.
Jones Day
In the August 14, 2014, Federal Register, FDA reopened the comment period for the draft guidance Best Practices in Developing Proprietary Names for Drugs.
Fox Rothschild LLP
The Department of Health and Human Services’ Office of Inspector General (OIG) recently completed a study of facilities’ records.
Fox Rothschild LLP
The Department of Health & Human Services’ OIG released a report of an analysis of Medicaid payments in the State of Louisiana for pediatric dental services.
Sheppard Mullin Richter & Hampton
We are seeing new efforts by the Obama administration to incentivize coordination across a spectrum of services provided to Medicare Fee-for-Service patients.
Reinhart Boerner Van Deuren S.C.
As of August 5, 2014, all packaged foods labeled "gluten-free" must meet the requirements of the U.S. Food and Drug Administration's final rule.
Reed Smith
On August 28, 2014, CMS announced the latest changes to the deadlines associated with the Sunshine Act "Open Payments" System review and dispute process.
Jones Day
The Treasury Inspector General for Tax Administration said the Internal Revenue Service should improve its compliance rules for the ACA medical device excise tax.
Jones Day
FDA recently issued a final guidance on Evaluation of Sex-Specific Data in Medical Device Clinical Studies.
Jones Day
Hydrocodone with acetaminophen has been the most widely prescribed drug since 2007, with more than 135 million prescriptions written in 2012.
BakerHostetler
In the world of healthcare policy and law, we usually discuss issues impacting providers, but don’t often report about the training and infrastructure.
BakerHostetler
The Clinica de la Mama case could well serve as an instruction manual of what not to do to stay out of the government’s crosshairs.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
The Obama Administration proposed to extend a religious exemption to providing contraception coverage to closely held for-profit corporations.
Fox Rothschild LLP
The FDA just released draft Guidance for Industry – Controlled Correspondence Related to Generic Drug Development.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
A federal district court recently dismissed a qui tam relator’s complaint in a declined case against the Hospital for Special Surgery.
Bradley Arant Boult Cummings LLP
No meeting was held in July. The next Certificate of Need meeting will be held on August 28, 2014, at 11:00 a.m.
McGuireWoods LLP
Castle Biosciences, headquartered in Friendswood, Texas, is a cancer-focused molecular diagnostics company which currently offers prognostic tests for patients.
Foley & Lardner
The Georgia Composite Medical Board enacted a new regulation governing the standards for telemedicine practice.
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Venable LLP
The Affordable Care Act (ACA) imposes new reporting requirements on employers and insurance companies offering health coverage.
Littler Mendelson
On January 10, 2014, the Internal Revenue Service released final regulations governing the employer shared responsibility provisions of the Affordable Care Act.
Troutman Sanders
This is the twenty-seventh in the series of alerts intended to keep employers up to date on the evolving requirements of Health Care Reform under the ACA.
Ropes & Gray LLP
The Food and Drug Administration took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices.
Jones Day
The Affordable Care Act ("ACA") infuses new complexities into collective bargaining negotiations over health insurance benefits.
Waller Lansden Dortch & Davis
The United States Department of Justice recently filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities, alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill.
BakerHostetler
Although HIPAA does not create a private cause of action, a recent Indiana Superior Court jury verdict demonstrates that HIPAA still could play an important role in private causes of action in state court based on negligence and professional liability as it relates to confidentiality.
Littler Mendelson
For several years, nurses’ unions have lobbied, with varying success, for legislation implementing nurse-patient ratios.
Ropes & Gray LLP
On December 26, 2013, the Office of Management and Budget ("OMB") published final guidance in the Federal Register entitled "Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards" ("Final Guidance"), to be located at Title 2 of the Code of Federal Regulations ("C.F.R.").
Navigant Center for Healthcare Research and Policy Analysis
17 days ago, I had total knee replacement surgery. After years of wear and tear, two meniscus repairs and persistent pain, I took the plunge.
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