Another Entry from the FDA’s Warning Letter Inbox

It has been a while since I reported on warning letters issued by the U.S. Food and Drug Administration (FDA) as part of its inspection, compliance, enforcement and criminal investigation activities. Well this post shows that the FDA continues to put violators on notice. As described in a previous article on this blog, FDA warning [...]

Latest FDA Guidance on Clinical Investigations

 Periodically, the U.S. Food and Drug Administration (FDA) publishes guidance to industry on various matters under its regulatory jurisdiction.  Typically, the agency would publish a draft copy and request input from the American public during a specific period.  Upon the expiration of the comments period, the agency publishes a final version of the guidance, which [...]

FDA Warning Letter to a Dietary Supplement Manufacturer

As part of its inspections, compliance, enforcement and criminal investigations activities, the U.S. Food and Drug Administration (FDA) issues warning letters to violators.  As described in a previous article on this blog, FDA warning letters fall into three broad categories depending on the nature of the violation and the corrective action required.   For example, [...]

FDA Warning Letter to a Pharmaceutical Manufacturer

As part of its inspections, compliance, enforcement and criminal investigations activities, the U.S. Food and Drug Administration (FDA) issues warning letters to violators.  As described in a previous article on this blog, FDA warning letters fall into three broad categories depending on the nature of the violation and the corrective action required.   For example, [...]

FDA Warning Letter to a Clinical Investigator

As part of its inspections, compliance, enforcement and criminal investigations activities, the U.S. Food and Drug Administration (FDA) issues warning letters to violators.  As described in a previous article on this blog, FDA warning letters fall into three broad categories depending on the nature of the violation and the corrective action required.   For example, [...]

FTC Permanently Stops Six Affiliate Marketers from Using Fake News Sites

As part of its ongoing crackdown on bogus health claims and false advertising, the Federal Trade Commission (FTC) conducted enforcement sweeps in 2011 against marketers who allegedly used fake news sites to promote weight-loss products.  The FTC alleged that the marketers designed websites, which falsely appear as if they were part of legitimate news organizations. [...]

FDA Warning and Close-Out Letters

As part of its regulatory compliance activity, the U.S. Food and Drug Administration (FDA) issues warning and close-out letters.  There are three types of warning letters, reflecting the nature of the compliance violation and the corrective action required from the violator. This article describes each type of warning letter, and provides a backdrop to our subsequent [...]

FDA Enforcement Report – January 18, 2012

The FDA publishes a weekly Enforcement Report, which details product recalls and field correction activity of the agency.  It is a vital resource for both industry and consumers.  Each report provides information about recalled products, including:      product name and code manufacturer and/or distributor volume of product in circulation geographical distribution of product reason [...]

Price Gouging Alert: CVS Caremark Corporation Settles FTC Deceptive Pricing Charges

CVS Caremark Corporation will pay $5 million to settle Federal Trade Commission charges that it misrepresented the prices of certain Medicare Part D prescription drugs – including drugs used to treat breast cancer symptoms and epilepsy – at CVS and Walgreens pharmacies. The allegedly deceptive claims caused many seniors and disabled consumers to pay significantly more [...]

FDA Enforcement Report – January 11, 2012

The FDA publishes a weekly Enforcement Report, which details product recalls and field correction activity of the agency.  It is a vital resource for both industry and consumers.  Each report provides information about recalled products, including:       product name and code manufacturer and/or distributor volume of product in circulation geographical distribution of product reason [...]