Entries by admin_fidj

USDA Warns Public of Organic Certification Fraud

On August 30, 2011, the U.S. Department of Agriculture (USDA) issued a press release notifying the public that a fraudulent organic certificate had been disseminated. The press release, found here, […]

FDA Publishes Draft Guidance for Evaluation and Labeling of Scored Tablets

On September 1, 2011, the U.S. Food and Drug Administration (FDA) released draft guidance for tablet scoring, see FDA Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation. This draft guidance provides recommendations regarding “guidelines to follow, data to provide, and criteria to meet and detail in an application to approve a scored tablet,” as well as nomenclature and labeling for approved scored tablets. This draft guidance applies only to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). These guidelines are optional for currently marketed drug products.

Del Monte Prepares for Suit Against Oregon

On August 29, 2011, Del Monte began taking steps to sue the State of Oregon’s Public Health Authority (PHA) and one of its senior officials. After suing the FDA last week, the company filed a notice to sue letter, alerting the State that it will be pursuing legal action in relation to allegations of tainted cantaloupes. According to Del Monte, Oregon’s PHA and its officials had insufficient evidence to link Del Monte cantaloupes to an outbreak of Salmonella Panama.

FDA Issues Import Alert for Papayas from Mexico

On August 25, 2011, the U.S. Food and Drug Administration (FDA) issued an Import Alert aimed at stopping the introduction of contaminated papaya from entering the country. As announced here, the FDA and its Mexican counterparts have been closely monitoring the salmonella contamination that has been linked to papaya grown in Mexico.