…years. On January 10, 2017 the DeCosters timely petitioned the Supreme Court for review of an Eighth Circuit decision upholding their three month prison sentences for misdemeanor violations of the…

…whether they complied with human subject protection guidelines; a “full statement of all components, ingredients, additives, and properties, and of the principle or principles of operation” of the product; and …

…products with the predicates and noted three differences:  absence of menthol; presence of fire standard compliant (“FSC”) cigarette paper (as opposed to conventional cigarette paper); and, changes to design features…

By Ricardo Carvajal – In an increasingly common exercise of the agency’s authority under FDC Act § 404, FDA announced that is has it has suspended the temporary Emergency Permit…

During the past several years, government enforcement authorities have focused an increasing amount of attention on the marketing activities of medical device companies.  This increased scrutiny has taken the form…

…reached in 2005.  FDA’s denial notes that the agency may revisit its decision as warranted by the emergence of new scientific evidence or changes in consumption patterns. By Ricardo Carvajal…

…on responses, additional sections, questions, data fields, and places to link files, called attachments, are added. For example, answering “yes” to the question related to use of software/firmware opens new…

…when it comes to meeting minutes. Sponsors should ensure that at least one person at the meeting is solely responsible for taking minutes. The minutes should not be a transcript…

…records of subjects in clinical trials and billed pharmaceutical companies for work that was never done. The indictment does not name the seven drug companies that were the victims of…

…stakeholders improves understanding on both sides. We appreciate FDA taking the time to present this information, and more importantly, to allow such a substantial portion of time to answer questions….

…an alternate source of raw material, and was intended for laboratory testing purposes only, not for use in humans or animals. Both entries of material were tested by FDA in…

…for discussing complex legal and regulatory issues associated with food, drugs, cosmetics, medical devices, and other health-related products. 2024 brings a host of HPMers who have important roles at FDLI…

With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns,…

…do not have a judicial process, there are significant technical and procedural safeguards in place, with processes negotiated with unions. The U.S. Anti-Doping Agency (USADA) also follows extensive policies and…

…by potential generic competitors, but the FDA mayor may not decide to give final approval to competing generics and it mayor may not decide to give final approval in a…