Read Administrative Law updates, alerts, news, and legal analysis from leading lawyers and law firms:
Konczal: Dodd-Frank Reforms Get Roughed Up in Court
Medicaid Receiving Startlingly Little Attention As Everyone Discusses Medicare
Obama Administration Calls for Free Access to Federally Funded Research
Can Virginia Block Non-Residents from FOIA Requests? Supreme Court Hears Oral Arguments
Should Wall Street Fear Mary Jo White?
Looking Ahead to Washington State’s Legalized Marijuana Marketplace
Congressman: My Plan Would Reduce Student Loan Defaults: Video
Local Governments Continue to Fight States for Right to Govern Fracking
Tax Questions to Ask Yourself with the End of 2012 and the Fiscal Cliff Approaching
Obama Blocks Chinese-Owned Wind Project Out of Concerns for National Security
Crystal Ball Perspective: Will Healthcare Reform be Repealed if Romney Wins the Presidential Election?
Stewart Baker, Former GC of NSA, on Why the Cybersecurity Act Failed & Threat of Tomorrow’s Terrorism
Not Prepared for Healthcare Reform? Three things employers need to focus on now.
Who pays for road damage in Pennsylvania after ACT 13?
Smartphone Data Solution: Sharing Airwaves
The Apellate Process Explained - Kathi Sandweiss discusses the appeals process and what it can and can't do for your situation.
Marcellus gas fuels Natural Gas Vehicles
Natural gas encourages industrial and large commercial end-users to revisit their operational plans
NLRB Posting Rule Delayed Again, Will We Ever See Resolution?—McKenna Long's Seth Borden
Is there a way to safely use social media in the interview process?
Following its recent re-elevation to the ministry level and the appointment of a new Commissioner in March, Mr. Yong Zhang, former Director of the Food Safety Office under the State Council of China, the China Food and Drug...more
Executive Summary -
On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more
The U.S. Food and Drug Administration (FDA) recently released the fourth in a series of draft guidance documents on the approval pathway for biologicals that are biosimilar to or interchangeable with a reference biological...more
Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more
In a letter to compounding pharmacy PharMEDium, the U.S. Food and Drug Administration (FDA) stated it was no longer willing to accept an alternate method of satisfying the requirement for a patient-specific prescription. In...more
In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more
On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more
The Final Rule offers significant changes to patient rights and patient protections. (There is much more to the rule, but other aspects are not addressed in this post. Here you may find a link to the HIPAA Omnibus Rule, a...more
The final regulations from Department of Health and Human Services Office of Civil Rights (OCR) containing modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules (Omnibus Rule) have finally...more
Yesterday, the U.S. Department of Health and Human Services (HHS) released the long-awaited final rules implementing changes to the HIPAA privacy and security rules enacted in 2009 by the HITECH Act....more
The long awaited HIPAA/HITECH Final Rule is out. The final rule is effective March 26, 2013, but covered entities (CEs) and business associates (BAs) will have 180 days beyond the effective date to come into compliance....more
HHS has finally issued its omnibus HITECH Rules. Our firm will issue a comprehensive summary of the rules shortly, but of immediate import is the change to the breach reporting harm threshold. The modification will make it...more
To restate the obvious, hospitals operate in a risky environment. They face a variety of risks and a blanket of government regulations. You have to admire the Chief Compliance Officer at a hospital. They learn to live with...more
On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more
On January 2, 2013, HHS announced that the Hospice of North Idaho (HONI) agreed to pay $50,000 and enter into a Corrective Action Plan (CAP) as part of a settlement involving a breach of unsecured electronic protected health...more
CMS is seeking comments from hospitals, electronic health record (EHR) vendors, and other interested parties regarding whether hospitals could be ready as early as January 1, 2014, to electronically report patient-level...more
Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more
Healthcare suppliers and service providers live in a regulated world. They are constantly under audit scrutiny. Sometimes federal agencies (i.e private contractors) conduct the audits; other times state agencies conduct the...more
In This Issue:
- Six Things to Think About as Technology Advances
- For More Information
- Recent Health Care News You Should Know About
- Check Out Our Previous Tips
- Deep Thoughts for the New Year: Ethical...more
The Chinese State Food and Drug Administration (“SFDA”) announced a plan for regulatory reform (“Reform Plan”) and is soliciting public comments through January 15, 2013. The Reform Plan sets forth the following key strategic...more
On April 29-30, 2013, FDA will hold a public workshop to discuss standardizing the format and content of medical device labeling and the development of a public repository/database that would provide access to the labeling of...more
On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”).
Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by...more
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