Media Mentions
2008
Robert B. Nicholas was mentioned in the June 16 issue of the National Law Journal in an article regarding a new U.S. Food and Drug Administration final rule governing clinical trials held in foreign countries that will spark painstaking legal review of pharmaceutical companies' protocols for trials. "Adhering to the FDA's good clinical practices directives for studies done abroad means more work for clients and their attorneys. We'll be working with companies trying to structure clinical studies that they'll be conducting outside the U.S.," Mr. Nicholas said.
Robert B. Nicholas, Health, Life Sciences - Health
Arnold Friede, Jennifer Geetter, Robert Nicholas, and Paul Radensky had their On the Subject published in the May 30 edition of Health Law 360 regarding the FDA Draft Guidance on certification of compliance with the new FDAAA clinical trial registration and posting regime.
Arnold I. Friede, Jennifer S. Geetter, Robert B. Nicholas, Paul W. Radensky M.D., Health, Life Sciences - Health
Arnold Friede, Elizabeth Hack, Robert Nicholas, Paul Radensky and T. Reed Stephens were mentioned in a May 29 article in FDA Webview regarding the recent White Paper they had authored regarding Merck’s $58 million settlement of consumer fraud claims by state attorneys general.
Arnold I. Friede, Elizabeth I. Hack, Robert B. Nicholas, Paul W. Radensky M.D., T. Reed Stephens, Health, Life Sciences - Health
Arnold Friede and Robert Nicholas were quoted in the April 2008 issue of Medical Marketing and Media regarding scientific 'free speech' being threatened. "Calls for an investigation into support for the American Heart Association (AHA) and American College of Cardiology stating are likely to convince other scientific groups not to speak out on issues of public concern," Mr. Friede and Mr. Nicholas said.
Arnold I. Friede, Robert B. Nicholas, Health, Life Sciences & Medical Devices, Life Sciences - Health
Robert B. Nicholas was quoted on April 14 by the National Law Journal in an article regarding the U.S. Food and Drug Administration's plan to post employees in the People's Republic of China. The FDA announced plans to post eight full-time, permanent FDA employees in China within the next 18 months, plus five local Chinese nationals to work with FDA staff. "A shift in China's regulatory regime for drugs, medical devices and foods isn't going to happen overnight, but its creation and development will create opportunities for lawyers working with U.S. and Chinese manufactures in China for many years to come," said Mr. Nicholas. "It takes knowledge, experience and training to get people to understand the consequences of how they prepare documents for contracts and for submission to various regulatory agencies," Mr. Nicholas added.
Robert B. Nicholas, Food and Drug Administration - Alcohol Beverages & Products, Health
Arnold Friede and Robert Nicholas were mentioned in the April 2008 issue of Medical Marketing & Media (MMM) Online in an article regarding calls for investigation into support for the American Heart Association (AHA) and American College of Cardiology. "No one can question the status of the AHA and American College of Cardiology as scientific speakers in the debate about some of the most important public health issues of our time, even if they receive some financial support from commercial interests," Mr. Friede and Mr. Nicholas said.
Arnold I. Friede, Robert B. Nicholas, Health
Arnold Friede and Robert Nicholas were quoted in the February 22 issue of FDA Webview in an article regarding the statements issued by the American Heart Association and the American College of Cardiology regarding the results of the Vytorin ENHANCE study. "Given the core First Amendment value of scientific speech by AHA and ACC about the ENHANCE study results, and their unquestionably sensible— benign —recommendation that patients speak with their doctors before precipitously stopping Vytorin, the fact that they have become objects of congressional investigations and have even been asked to name names about the preparation of their respective statements, suggests that there is a chill wind on free speech blowing from Capitol Hill," Mr. Friede and Mr. Nicholas said.
Arnold I. Friede, Robert B. Nicholas, Health
Robert Nicholas was quoted in the January 14 issue of Product Liability Law 360 in an article regarding the growing "cosmeceuticals" industry. "When you work with clients who have products they want to bring to the market, frequently the question they ask is, 'What’s the fastest way to get it to the market?' There is a trade-off between speed to market and exclusivity or safety. In the absence of a safety issue, the FDA doesn't tend to aggressively regulate cosmetics. That's one reason why it's an attractive area for manufacturers, even if you have legitimate claims of 'pharmaceutical' results," Mr. Nicholas said.
Robert B. Nicholas, Health, Health - Product Regulation
2007
Robert Nicholas was quoted in a June 7 article published by The GMP Letter regarding the Form 483s and warning letters. "Firms should not be afraid to disagree with the FDA regarding inspectional observations cited in Form 483s and warning letters. The 483 or the warning letters are really FDA's observations. In fact, sometimes they're wrong," Mr. Nicholas said.
2005
Robert Nicholas was quoted in the June 23 issue of The Boston Globe in an article addressing medical device companies' procedure on product recalls.
Robert Nicholas was quoted in the Boston Globe on March 2 regarding the FDA asking Congress to give it more powers to dictate the warnings on drug labels. The FDA has strong authority to dictate labeling language before a drug is approved. "Once a product is on the market, it's like a property right," commented Bob. The FDA still has negotiating clout because if a drug company refuses its suggestions the agency could initiate legal proceedings to remove the drug from the market or it could ask the secretary of the DHHS to declare a drug an imminent hazard. "There are lots of informal rules -- there is jawboning and discussions," Mr. Nicholas said.
Robert B. Nicholas, Agribusiness, Food & Beverage
2002
Robert Nicholas was quoted in the October 7 issue of Food Chemical News regarding the FDA Commissioner candidate Mark McClellan. Mr. Nicholas mentioned that the scheduling of Mr. McClellan's confirmation hearing in the Senate, prior to the November election, exemplifies that Congress recognizes the need for a full-time leader at the FDA.
Robert B. Nicholas, Food & Beverage
Robert Nicholas was quoted in the March 11 issue of Food Chemical News in regarding the possible appointment of Lester Crawford as the chief of the FDA.
