by Darshan Kulkarni | Jul 19, 2016 | Administrative, Compounding
Introduction The FDA’s purpose is to protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices and our nation’s food supply, cosmetics and products that emit radiation. It is also... 
by Darshan Kulkarni | Feb 11, 2016 | Administrative, Ethics, Guidances
Introduction On Sept 15th, 2015 the DOJ using “the Yates memo” announced a policy which revised their principles of corporate prosecution. They announced that corporations wont be able to settle fraud cases unless they divulge the names of the people involved. These... by Janki Patel | Apr 2, 2013 | Administrative, Drugs, FDA, Recalls, Safety
Introduction In a drug recall, the manufacturer of a prescription drug or over-the-counter medicine takes its product off the market. Sometimes the U.S. Food and Drug Administration (FDA) requests the recall, while at other times the manufacturer initiates the recall.... by Susan Towers | Jul 5, 2012 | Administrative, FDA
Introduction: Off-label uses of prescription drugs are common, especially in the treatment of cancer. Results from a Canadian study released in May using electronic medical record data showed that out of 250,000 prescriptions, 11% were for off-label uses. The study... by Darshan Kulkarni | Jun 26, 2012 | Administrative
Continued from Has the push for transparency gone too far? (Part 1) Why the big deal Without the appropriate connotations as to why these payments were made, the Sunshine Act seems to cast physicians in a bad light. Additionally, to avoid being cast in this bad light,... by Darshan Kulkarni | Jun 14, 2012 | Administrative
Background There has been a recent surge in requests for disclosures of relationships between individuals and pharmaceutical, biopharmaceutical, and medical device companies (collectively, “Industry”). These calls for transparency are often from individuals who...
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