…procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person” (emphasis added),…

…baseline AMP of the original product to line extensions for purposes of calculating the so-called “additional rebate” for innovator drugs.  The additional rebate penalizes price increases exceeding the rate of…

…in the medical products agency because: the supplement category includes not only vitamins, minerals and other clearly nutritional substances but also herbal products and others that are marketed and sought…

…that “[a]ll five study countries have increased nonprescription drug availability since 1995; however, the impact of restricted nonprescription drug classes on drug availability is unclear.”  The report also identifies several…

…establish such procedures.  See id. § 199.21(q)(3)(i).  The regulation provides that the refund procedures must, “to the extent practicable, incorporate common industry practices for implementing pricing agreements between manufacturers and…

…“are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.”  Evidently, FDA feels it necessary to specifically put all parties on notice that a “no questions”…

…recently-enacted FDA Amendments Act (“FDAAA”).  FDA also made available a “Questions and Answers” document explaining the Federal Register notice and discussing, among other things, when a decision will be made…

…Orphan drug designations and approvals (which include not only approvals of NDAs for new molecular entities and BLAs for original biological products, but also applications approved for new orphan uses…

…institution to whom patients consented to donate their tissue samples — retained ownership. Pharmaceutical and biotech companies routinely use banked biological tissue specimens for product development and other purposes.  This…

…violated the law by not treating like cases alike and by imposing arbitrary and unequal burdens on similarly situated parties.  “FDA has violated these settled principles of reasoned decision-making by,…

…dispensed and delivered to patients for a legitimate medical purpose. However, the well-intentioned statutory language enacted in 1970 did not anticipate important changes in clinical therapies and advances in medical…

…antitrust immunityconferred by a patent, see, e.g., United States v. Line Material Co., 333 U. S. 287, 310, 311, and the antitrust question should be answered by considering traditional antitrust…

…all up: The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act’s intended balance of incentives for cost savings and continued…

…application sponsor failed to obtain tentative approval within 30 months of ANDA submission.  But the story does not end there.  As with so many Hatch-Waxman 180-day exclusivity cases, it’s complicated. …

…for their position that reprints are beneficial.  In fact, while many companies’ marketing practices will be unaffected by the draft GRP guidance, more aggressive companies may find their marketing practices…