FDA


FTC to Focus on Unsubstantiated Health Claims
January 30, 2019 | Steven Shapiro | FDA | Fraud and Abuse | Litigation | Pharmaceuticals
On January 28, the Federal Trade Commission (FTC) published on its Business Blog a post titled “Hey Nineteen: Nine FTC developments that could impact your business in 2019.” Of most importance to the healthcare industry is the FTC’s promise to focus on unsubstantiated health claims in advertising. The relevant paragraph of the post reads as …
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Diabetes Pill Marketers Settle FTC Complaint
December 14, 2018 | Steven Shapiro | FDA | Fraud and Abuse | Litigation | Pharmaceuticals
On December 4, the Federal Trade Commission (FTC) announced the settlement of a complaint against Nobetes Corporation, which marketed and sold a pill that supposedly treats diabetes. The FTC complaint had alleged that the company made false or unsubstantiated health claims, engaged in illegal billing practices, and used deceptive endorsements in the marketing and sale …
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DOJ Files Amicus Brief Declaring Intention to Dismiss FCA Case
December 12, 2018 | Geoffrey R. Kaiser | FDA | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Pharmaceuticals
On November 30, the U.S. Department of Justice (DOJ) filed an amicus curiae brief urging the U.S. Supreme Court to deny a petition for a writ of certiorari filed by Gilead Sciences, Inc. from a Ninth Circuit Court of Appeals decision which had revived a declined False Claims Act (FCA) lawsuit brought by two former …
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FDA Reviews Clinical Research Approval Process
November 28, 2018 | Cassandra Rivais DiNova | FDA | Legislation and Public Policy | Pharmaceuticals
The U.S. Food & Drug Administration (FDA) has contracted with Eastern Research Group, Inc. (ERG) to review the FDA’s investigational new drug (IND) approval process. The IND phase of drug development is when human trials of new drugs are conducted. The FDA receives 4,000 IND requests a year. In order for a new drug to …
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