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…that [Franck’s] will resume the challenged conduct,” and the company “has turned in the permits required by Florida law to operate as a compounding pharmacy, sold all its assets, and…
…Organic Products Act of 2003 (“COPA”) prohibits any product handled, processed, sold, advertised, represented or offered for sale in California from being sold as organic unless it is labeled with…
By William T. Koustas – We have been following the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA for over two years (see here, here, here, here, and here. On…
…the pharmacological effects of synthetic cathinones are similar to those of highly abused products such as methamphetamine, cathinone, methcathinone and MDMA. They cause, among other effects, agitation, tachycardia, dilated pupils,…
…other things, pharmaceutical manufacturing companies (as defined in the marketing law, Mass. Gen. Laws ch. 111N) to provide a discount, rebate, voucher, or other reduction in a patient’s out-of-pocket expenses…
…seeking approval of its proposed drug product by established name, if any, proprietary name, dosage form, strength, route of administration, name of listed drug’s application holder, and listed drug’s approved…
…products being exchanged between the two countries, and, by extension, across the globe. Understanding the current legal, regulatory, and economic environment for the development and sale of pharmaceuticals, medical devices,…
By Jamie K. Wolszon & Jeffrey N. Gibbs – On February 15, 2012, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted supplemental comments to FDA’s June 1, 2011 draft guidance (see our…
By Riëtte van Laack – On Monday, January 23, 2012, the U.S. Supreme Court ruled that a California state law prohibiting the slaughter, processing, and sale of any non-ambulatory animals…
…published by Politico, Commissioner Rosch stated that he does not think the Preserve Access to Affordable Generics Act should be tacked onto any piece of legislation, but rather, should stand…
…treatment claims are also live and subject to judicial review, because, among other things, they are capable of repetition with other allegedly grandfathered products the companies manufacture and distribute (e.g.,…
…111 (1942), FDA argues that “given the collective impact on commerce of intrastate manufacturing, processing, packaging, transporting, distributing, receiving, or holding of food in the United States, FDA has concluded…
…after the CRCC letter and , presses the Administration to federally decontrol cannabis. The July 6th letter, signed by Senators Elizabeth Warren, Cory Booker, Bernie Sanders, Edward Markey, Kirsten Gillibrand…