…issues for medical gases despite the statutory requirement in FDASIA to issue a final rulemaking addressing all necessary changes for medical gases by July 9, 2016. Designated medical gases are…

…seeking approval for the treatment of pediatric patients with Tourette’s Disorder.  On December 12, 2014, FDA approved the Supplemental NDAs stating, among other things, that “[t]hese ‘Prior Approval’ supplemental new…

…are chemically and biologically identical might nonetheless bear different safety information, confusing patients and prescribers alike.  The labeling on the generic products should be ide tical to the labeling on…

…and final guidance clarify that: Under existing FDA regulations, ANDA holders cannot make labeling changes through the formal supplement process under 21 CFR 314.70 in all circumstances in which NDA…

…number of critical health areas, American consumers and industry are faced with no guidance at all or inconsistent messages on many important issues. The following is a list of examples:…

…obtained and the trial concluded. Further, international standards for medical research require trial sponsors to allow participants to access the studied treatment even after the trial’s conclusion. The Court here…

…some standards do not allow salt replacement by salt substitutes); questions as to the purpose of SOIs (is it related to nutrition or to assure authenticity of the food, or…

…policies that, on their face, do not allow educational grants to be awarded for unlawful purposes.  However, corporate policies still allow this industry to walk a fine line between violating…

…that Classen wants to draw the line between pre-market commercial use and post-market commercial use. But this raises a question of how much commercial use should be considered given that…

…deceptive” practices. Deceptive practices are the frequent bedrock legal theory for these cases. Tech companies that don’t live up to their promises to safeguard consumer data are frequent targets of…

…calls Equal Voice, intended to ensure the equal participation of all relevant parties.  OSE and OND signed a Memorandum of Understanding in June 2008 that states the agency’s intent for…

…companies that don’t de-list. Indeed, that one line in the Notice letters FTC sent may end up being really critical if companies don’t willingly de-list. But if FTC takes this…

By Ricardo Carvajal – In an apparent effort to leverage against the scientific resources of other federal agencies, FDA’s National Center for Toxicological Research (“NCTR”) has entered into a Memorandum…

By Carmelina G. Allis – The FDA has issued a Federal Register notice announcing a program that establishes a timeframe for the submission and agency review of responses to Form…

…“false or misleading.”  Id.  Although there are several requirements for the labels of beverages containing multiple juices, Pom’s complaint “does not reference or attempt to enforce these requirements.” Id. at…