Mondaq USA: Food, Drugs, Healthcare, Life Sciences
With news that 3D printing can be used to produce guns, we must now ask ourselves what other things might be built using a 3D printer.
In recent months, FDA has been ramping up inspections of manufacturers who have pending filings for approval, notifications and other regulatory clearances.
Following a similar initiative on the House side, leaders of the Senate Finance Committee are inviting provider input on Medicare physician payment system reform.
The USPTO still is considering information gathered during its RCE Outreach program, but it has made some internal changes.
A summary of the Alabama CON review board updates.
Dr. Don Williamson presented an update to the Committee on the Alabama Department of Public
Health Licensure Advisory Board’s April 30 meeting at which proposed licensure regulations for freestanding emergency departments were approved.
That political considerations impact federal agency regulatory decisions is a discovery as shocking as the discovery that there is gambling in casinos.
On May 8, 2013, the House Energy and Commerce Subcommittee on Health approved by voice vote H.R. 1407, legislation to reauthorize and combine the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act.
On May 8, 2013, the US Department of Health and Human Services, Office of Inspector General issued a "Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs" ("2013 Bulletin").
A discussion which looks at the passing of legislation mandating that a certain number of nurses be staffed for every patient, in a number of U.S. states.
The Centers for Medicare & Medicaid Services temporarily delayed the implementation of edits relating to ordering/referring practitioners that were scheduled to go into effect May 1, 2013, and issued a proposed rule with revisions to its enrollment regulations.
The Internal Revenue Service has recently officially issued the proposed regulations addressing the requirement under Section 501(r)(3) of the Internal Revenue Code that tax-exempt hospitals conduct community health needs assessments.
A discussion on a case which illustrates the potential value of pursuing a variety of claims that focus on different aspects of the same invention.
The FDA recently issued a proposed rule to allow the use of stand-alone symbols on the labels of medical devices.
On May 6, 2013, CMS published a proposed rule to update Medicare skilled nursing facility PPS rates for FY 2014 and make other updates to SNF reimbursement policy.
This week we celebrate National Nurses Week.
A summary of the most recent health care reform implementation updates.
On April 17, 2013, the Office of Inspector General ("OIG") of the United States Department of Health and Human Services released a revised Self-Disclosure Protocol that updates previous guidance for how health care providers can voluntarily disclose and resolve instances of potential fraud involving Federal health care programs such as Medicare and Medicaid.
A list of the most recent healthcare updates.
Graduate medical education programs and residents should be getting used to change by now.
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The Supreme Court of the United States has recently heard oral argument in "Association for Molecular Pathology v. Myriad Genetics, Inc." to decide the question, "Are human genes patentable?"
On April 10, 2013, President Obama released his budget proposal for fiscal year (FY) 2014 (the Budget).
The 2010 theft of an unencrypted laptop containing confidential health care information made front-page news in 2013, not because a huge number of patients were affected, but for the exact opposite reason.
As anticipated, last Friday (April 5, 2013), USCIS received enough cap-subject H-1B petitions to meet or exceed the available number of H-1B spots for Fiscal Year 2014 (FY 2014).
The Departments of Labor, Treasury, and Health & Human Services have issued new guidance on the content requirements for health plan summaries of benefits and coverage ("SBCs").
As part of the Patient Protection and Affordable Care Act, more commonly known as Obamacare, Congress also passed the Physician Payment Sunshine Act.
The Final Call Letter addresses a wide variety of issues that will affect all parties involved in Medicare Advantage and Medicare Part D arrangements, including plans, beneficiaries, providers, and administrative services entities, such as pharmacy benefit managers.
On January 17, 2013, the federal Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"), issued the long-anticipated final omnibus amendments.
Marilyn Tavenner received bipartisan support from members of the Senate Committee on Finance in her confirmation hearing to lead the Centers for Medicare and Medicaid Services (CMS) though a full Senate vote is being held up, the president released his FY 2014 budget proposal with health care reform and specified reimbursement reductions to providers and manufacturers totaling $400 billion over 10 years sprinkled throughout it, and Department of Health and Human Services (HHS) Secretary Sebelius
The Massachusetts Department of Public Health Public Health Council approved, by unanimous vote, final regulations for the implementation of the medical marijuana ballot initiative law.
