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
4 Things to Know About Michigan’s New Right-to-Work Laws
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Crystal Ball Perspective: Will Healthcare Reform be Repealed if Romney Wins the Presidential Election?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
The U.S. government may be resurrecting the "Park Doctrine" as a tool to prosecute the owners of pharmacies for federal Food, Drug, and Cosmetic Act (FDCA) violations. In United States v. Park, 421 U.S. 658 (1975), the U.S....more
On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding....more
With as many as 13,000 patients possibly exposed to fungal meningitis from tainted spinal steroid injections traced to a New England compounding pharmacy, the regulation of compounding pharmacies is once againheating up. The...more
A recent study published in the “Proceedings of the National Academy of Sciences” found that Bisphenol A (BPA) can adversely affect fetal development in rhesus monkeys. The study’s findings raise concerns regarding BPA...more
Originally published in Medical Devices Law & Industry Report on 10/03/2012.
FDA’s New Plan -
The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase...more
Originally published in the American Health Lawyers Association, Washington, D.C. on October 17th, 2012
New England Compounding Center (NECC) distributed contaminated syringes that caused a meningitis outbreak – killing...more
In This Issue:
- Top News…1
- State News…5
- Regulatory News…8
- Additional Reading…8
- Federal Register…9
- For More Information…12
- Excerpt From Top News:
Congress, FDA Weigh...more
A New Jersey federal court granted summary judgment to Baxter Healthcare Corporation (Baxter) last month based on a familiar legal concept rarely applied in the Garden State – warning causation. In Baker et al. v. APP...more
After six years of bribing American doctors, pushing antidepressants on children and hiding the heart attack risk of a diabetes drug, the British drug Company GlaxoSmithKline LLC got a slap on the wrist yesterday....more
In April 2012, Eric Esswein, an industrial hygienist from the National Institute for Occupational Safety and Health, made a statement at a conference sponsored by the Institute of Medicine that was guaranteed to attract the...more
The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In Stengel v....more
China’s State Food and Drug Administration recently issued draft guidance on drafting and preparing Periodic Safety Update Reports for drugs and is seeking comments from the public until 16 April 2012.
China’s State Food...more
State and federal courts reject efforts to categorize salmonella as a "communicable disease."
While the quality of the United States' food supply continues to be exceptionally reliable, problems do occasionally arise....more
In mid-December of 2011, following the recommendation of the Government Accountability Office (GAO), a bipartisan group of senators introduced the Medical Device Patient Safety Act. According to the GAO, the Food...more
Par filed suit seeking a judgment declaring FDA’s regulations unconstitutional and preventing FDA from deeming lawful First Amendment protected speech as evidence of criminal intent. In response, FDA is seeking early...more
Putting a snag in New Year’s resolutions for pound-shedding, the FDA and the FTC recently sent out warning letters to several companies that sell HCG-based diet products online. (These companies include Nutri-Fusion Systems...more
On Sept. 29, the Appellate Division took a significant step forward in clarifying and reinforcing the presumption-of-adequacy defense provided to manufacturers of prescription drugs under the New Jersey Product Liability Act...more
Four ex-officers of a Pa.-based manufacturer of a bone cement product were sentenced to prison for an unapproved trial that led to three deaths. Each pled guilty to a single misdemeanor count of shipping adulterated and...more
A great Chicagoan, Ernie Banks, was famous for saying “Let’s play two” – an expression of pure joy about the game of baseball. Another great Chicagoan, Judge Richard Posner, recently came out with a pair of opinions that...more
A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon...more
We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal. Here's one. Today, in Degelmann v....more
The Centers for Disease Control and Prevention (CDC) is working with public health officials across the country and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) to determine the cause of...more
On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.”1 Once finalized, the document will...more
Since the first sneeze, people have been trying to cure the common cold. While the cure remains elusive, everyone has a remedy for its symptoms – chicken soup, salt water gargle, fresh chopped garlic on crackers and, our...more
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