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…of the prescription at the time that it is completed (or, in the case of an emergency oral prescription, directly stating to the pharmacist when such prescription is communicated to…
…hospitals, cancer hospitals that are not paid under a prospective payment system, critical access hospitals, rural health clinics, Indian Health Service facilities, Federally Qualified Health Centers, and others. Covered Drugs:…
…RCTs in any litigated case. Commissioner Rosch disagreed, stating that the FTC required RCTs many years ago in Thompson Medical Co., 104 F.T.C. 648, 842-43 (1984), aff’d, 791 F.2d 189…
…Washington Legal Foundation and Allied Educational Foundation, several generic drug manufacturers, the Product Liability Advisory Council, Inc., DRI–The Voice of the Defense Bar, the Chamber of Commerce of the United States…
…(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or…
…here, here, and here – that allegedly cover infliximab.) When we last left off with the Sandoz case, the company had filed its opening brief with the Federal Circuit, saying,…
…Ipsen Biopharmaceuticals, Inc. v. Azar, Ipsen had obtained approval in 2007 for Somatuline Depot for the treatment of acromegaly. In 2014, FDA approved two supplemental NDAs (sNDAs), one for changes…
…in NDA 6624, Metabarin, an oral suspension, is a barium contrast medium used in the roentgenographic (X-ray) visualization of the esophagus, stomach, and intestinal tract. The NDA indicates that Metabarin…
…statute. (As folks might recall, FDA approved ANGIOMAX at 5:18 PM on Friday, December 15, 2000, and MDCO submitted its PTE application to the PTO on February 14, 2001 –…
…approval of generic drugs for reference products that lack significant competition, a CGT designation offers applicants benefits, like enhanced communications with FDA officials, expedited ANDA review, and potential eligibility for…
…final decision regarding whether to adopt, in whole or in part, or not at all, the ALJ’s Initial Decision. Oral argument before the Commission is scheduled for August 23, 2012….
…drug products’ conditions of use, composition and labeling, while the 1938 clause focuses only on a comparison of their conditions of use. Any attempt by FDA to impose the same…
…with respect to such products (see here, page 142; here, page 102; and here, page 81), including directing FDA to issue guidance on the development of abuse-deterrent drug products as…
Earlier today, the U.S. Supreme Court announced a 4-4 split in Warner-Lambert v. Kent – just a few days after hearing oral arguments on February 25, 2008. The case, which…
On September 24, 2007, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking that would expand the classification of dronabinol, commonly known as delta-9-tetrahyrdocannabinol (“THC”), as a Schedule…