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.
Bleeding Deaths Linked to Pradaxa
Lawsuits Claim SSRIs Can Cause Severe Birth Defects
Monster Energy Drink Accused of Teen Death
Digital Health: Where is the Action for Entrepreneurs?
In This Issue: Linda Goldstein to Provide Insight on FTC’s Dot Com Dislosure Guidance at Upcoming Bloomberg BNA Webinar; “All Natural” False Ad Suits Continue, Stalled; Wake Up! FDA Considers Caffeinated Foods;...more
Imagine your doctor recommends routine spleen removal surgery. When discussing your surgical options, the doctor tells you about da Vinci® - an increasingly used surgical robot. The doctor raves about the safety,...more
Doctors prescribe medicine to help keep us healthy. However, a mistake that leads to the wrong medicine being taken can cause serious injury or death. Unfortunately, these types of errors are not uncommon....more
Dear Doctor letters were front and center in the just-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
The FDA announced that it is conducting an investigation into the use of caffeine in foods and beverages. Since the FDA’s announcement, the energy drink industry has continued to receive significant media attention. On May 6,...more
In this issue’s installment of “Dealmaker’s Corner,” Jon Finger, a partner in our private equity group, had the opportunity to visit with Kyle Bradford, Managing Director with American Capital, Ltd., concerning the...more
Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...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
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
Yesterday, we reported that FDA had announced its intentions of reclassifying sunlamp products and requiring labeling changes to include warnings discouraging young people from using them....more
Harsh Criticism for Ad Industry Over DNT - The advertising industry faced harsh criticism at a hearing held by Sen. Jay Rockefeller (D-W.V.). He addressed the implementation of a federal Do Not Track program and...more
After issuing a public warning regarding the dangers of tanning nearly three years ago, this week the U.S. Food and Drug Administration (“FDA”) issued a proposed order to reclassify sunlamp devices and require labeling...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 Scheduled....more
On the heels of Wrigley’s new promotion of its new caffeinated gum called Alert Energy, FDA has announced that it will be investigating the safety of caffeine in food products. The use of caffeine in food products has been 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
Our firm is investigating possible violations of federal securities laws by officers and directors of Intuitive Surgical, Inc. (Intuitive Surgical) (Nasdaq: ISRG). A class action lawsuit has recently been filed against...more
In 2009, the U.S. Food and Drug Administration (FDA) announced that it intended to release a guidance document explaining how it will regulate industry’s use of social media to advertise products or communicate with...more
The number of mobile applications (apps) available to consumers on their iPhones, Androids, and iPads is astonishing. As of January 2013, there were more than 775,000 different apps available to iPhone and iPad users. It...more
Environmental and Policy Focus - ..Bills to create CEQA courts hinge on funding question: California lawmakers are considering legislation that would assign specialized judges to hear California Environmental...more
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more
Yesterday, the Michigan Department of Agriculture and Rural Development hosted officials from the Food & Drug Administration at a "Listening Session" on the newly proposed rules under the Food Safety Modernization Act (FSMA),...more
Contraceptives were the subject of the Federal Circuit's recent decision in Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. But, unfortunately, it's a rather fact-specific case with nothing of prurient...more
We are at the forefront of Chicago law firms representing women injured by surgical mesh, a product used to treat pelvic organ prolapsed (POP) and Stress Urinary Incontinence (SUI). Made of woven polyester, polypropylene or...more
Watch this news video if you or anyone you know is on a blood thinner. It could provide life saving information. Pradaxa, an anticoagulant medication, helps prevent blood clots and strokes. It’s often used with people who...more
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