The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.
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Monster Energy Drink Accused of Teen Death
Digital Health: Where is the Action for Entrepreneurs?
"Dear Doctor" letters were front and center in the recently tried case of Tietz v. Abbott Laboratories Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more
California federal courts, particularly those in the Northern District, have become a magnet for food labeling litigation—in particular, cases challenging “All Natural” labels on products containing genetically modified...more
An interagency working group – composed of the Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC) – is seeking...more
On June 2, 2013, U.S. Food and Drug Administration (“FDA”) Commissioner Margaret Hamburg delivered a speech at the American Society of Clinical Oncology’s annual meeting, in which she explained that the FDA is in the process...more
The US District Court for the Western District of Texas certified a class of common stock purchasers in an action against Pain Therapeutics, Inc. (PTI) and its directors. The plaintiff’s complaint, which alleges that PTI...more
In This Issue: Leading the News; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearing and Mark-Ups Scheduled. Excerpt from Leading the News...more
In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more
In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more
On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. ...more
The City of San Francisco is suing Monster Beverage Corporation for aggressively marketing its highly caffeinated energy drinks to teens and children. The company sold over $2 billion in these drinks in 2012. Lawyers.com...more
The outbreak of a serious liver viral infection, Hepatitis A, has been linked to a frozen berry product distributed by Costco, according to the Food and Drug Administration. So far, 79 people in seven states, including...more
In This Issue: - Top News ..CMS Finalizes MLR Rule for Plans, Maintaining Application to Part D Sponsors ..Early State Filings Show Premium Reductions under ACA ..HHS Received More Than 830 Letters of...more
Pharmaceutical and medical device companies have enough to worry about when it comes to enforcement risks....more
In a newly released Chief Counsel Advice, the Internal Revenue Service (IRS) Office of Chief Counsel treated a collaboration arrangement relating to the development and commercialization of a drug as a deemed partnership for...more
One of the rare California Proposition 65 trials began on April 8, 2013 – the Environmental Law Foundation (ELF) suit in Alameda County, CA Superior Court (ELF Lead In Food Case, available at...more
Laboratory-developed tests (“LDTs”) appear to be under FDA’s microscope once again. These tests, which include genetic tests, companion diagnostics, and genetic tests, are developed and performed by a laboratory and have been...more
According to a recent Business Insider story, the future of 3D printing is now. If recent news headlines are anything to go by, BI is onto something: from saving the life of a child with a custom-made airway tube to creating...more
In This Issue: Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more
As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more
In late May, the U.S. Food and Drug Administration took regulatory action against a mobile medical application or "mHealth" app for the first time. In its "It Has Come to Our Attention" letter to Biosense Technologies Private...more
Though the first nanoparticulate drug formulation was approved by the U.S. FDA way back in 1995, a recent flurry of deals and product approvals have shown increasingly high valuations for nanomedicine companies....more
An interesting debate recently occurred in the New England Journal of Medicine between a physician and the U.S. Food and Drug Administration (FDA) regarding whether the letters X and Z are used too frequently in...more
Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more
On May 21, 2013, the Food and Drug Administration (“FDA”) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited, the developer of the uChek Urine Analyzer app. The app, available since April...more
In This Issue: • Patent Office Must Prove Prior Art Reference Is Enabling • Complaint Was Adequate Despite Non-Infringing Possibilities • FDA Approval Not Relevant to Obviousness Analysis - Excerpt from...more
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