Earlier this fall, in accordance with its MDUFA IV commitments, CDRH launched an online platform that allows sponsors to track the status of its submissions. The platform is called the…

…establish requirements for the sale of food online, including access to label or labeling information prior to purchase The bill does not include any provisions to fund the work to…

…the final rule does not cover MUSA claims in all advertising. Instead, it covers labels appearing in all contexts, whether, for example, they appear on product packaging or online. FTC…

…device intended for commercialization, test methods, especially for extraction, and interpretation of results. On March 19, 2021, FDA announced the launch of an online Biocompatibility Assessment Resource Center to provide…

…are taking to alleviate disruptions; and how these companies allocate products among their stores when they are in short supply.” The orders also seek internal company documents such as “strategies…

…Medical School, Columbia University, Vanderbilt University, the University of Minnesota, and other leading genomics and regulatory institutions will convene online to tackle these issues. Hyman, Phelps & McNamara PC is…

…adverse event data for products it marketed. While BioTe Medical (who was inspected by FDA) evidently had an online portal to collect adverse drug event information, and collected over 4000…

…14, 2024, which can be submitted online. We hope the final guidance provides more clarity on use of informal interactions with the Agency as a method of getting feedback. We…

…to: (1) identify and prioritize chemicals of concern, evaluate alternatives as well as to specify regulatory responses (Assembly Bill 1879); and (2) establish an online Toxics Information Clearinghouse to provide…

…new online portal for manufacturers to review their reports, submit Suggestions of Error, and make rebate payments. CMS will provide all manufacturers of Part B and Part D rebatable drugs…

…alone would be worth the price of admission (if admission weren’t free). Those coming late to the party can still join in remotely by registering for the online webcast here….

…FDA to conduct an analysis of drugs that may be vulnerable to a shortage, and to publish the notifications it receives under § 356c online. The “Preserving Access to Life-Saving…

…since 2013 by DRDMG or its predecessor, the Division of Gastroenterology and Inborn Errors Products (DGIEP), only 1 out of 18 went to an advisory committee meeting. The online records…

…§ 45a does not extend to online and mail order claims as that provision refers to product labels, not to other labeling or advertising. Comments may be submitted until 60…

…CLE credits for New York, California, Illinois, and Minnesota. Register now to attend in-person or online. The event is presented at the Ropes & Gray, LLP, offices in Boston in…