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Is the FDA Exceeding its Authority?

Is the FDA Exceeding its Authority?

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...
Why promotional teams should worry about the Yates memo

Why promotional teams should worry about the Yates memo

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...

Is Pfizer's Reputation in Jeopardy after Huge Recall of Birth Control?

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....

Does the False Claims Act Restrict the Free Flow of Medical Knowledge?

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...

Has the Push for Transparency Gone Too Far? Part 2

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,...

Has the Push for Transparency Gone Too Far?

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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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.
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