Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act.
Learn More »A petition for writ of certiorari was filed in the U.S. Supreme Court on October 2, 2008, in Colacicco v. Apotex, Inc. The petition was filed by relatives of suicide victims after the U.S. Court of Appeals for the Third Circuit ruled that the FDA's rejection of suicide warnings for antidepressant labels, in it's pre-2004 public releases determining that there was insufficient scientific evidence to link adult use of the drugs and suicidality, preempted state tort failure-to-warn actions. The petition argues that the drugs' labels were proven inadequate by the FDA's subsequent regulatory actions requiring augmented warnings for all antidepressants. While the Supreme Court will hear Wyeth v. Levine on preemption this term, the decedents' relatives argued that their petition, presents important questions concerning whether misbranding is a valid basis for conflict preemption when drug companies add warnings of the increased risk at issue without prior FDA approval and the FDA does not pursue misbranding, and when the FDA itself subsequently requests warnings of the increased risk after a patient's death or injury. Colacicco v. Apotex, Inc. (3d Cir. 2008) petition for cert. filed (U.S. Oct. 2, 2008) (No. 08-437). Read More
For more information regarding this topic, see the Food, Drug and Cosmetics Law Reporter. The Reporter provides the full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Devoted primarily to the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act and the Comprehensive Drug Prevention and Control Act. Learn more.
Food, Drug and Cosmetics Law Reporter
Everything you need to know about Food and Drug Regulations.Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Learn More » |
Medical Devices ReporterAccess the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices. Learn More » |
