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…arguments raised by the defendants, including but not limited to a separate motion by generic defendants based on the Supreme Court’s analysis of the availability of CBE to generic manufacturers…
…generic drug access and creates a new 180-day exclusivity incentive to encourage the development of so-called “competitive generic therapies.” Finally, Title IX makes technical and miscellaneous changes to the law….
…Balance Between Innovation and Access,” is part of Commissioner Gottlieb’s Drug Competition Action Plan, which he indicated was forthcoming during a May 2017 House Appropriations Committee hearing. The meeting is…
…House are interested in a timely reauthorization, with Energy and Commerce Committee Chairman Greg Walden (R-OR) stating that the House is “fully committed to a timely reauthorization of the agreements”…
…establishing the Fiscal Year 2017 (“FY 2017”) user fee rates for several programs, including: Prescription Drug User Act (“PDUFA”) Fee Rates Biosimilar User Fee Act (“BsUFA”) Rates Generic Drug User…
…(Robins Kaplan LLP) will present a primer on strategies for generic drug manufacturers to get around API patents, using the 505(b)(2) application. This route can enable a generic company to…
…global pharma companies to the threat of simultaneous enforcement actions in multiple jurisdictions. Pharma companies as a consequence are redoubling their efforts to preach and practice ethical compliance worldwide. But…
…“Patent Challenge,” or 180-day exclusivity) for ANDA 205307 for Propofol Injection, 10 mg/mL, expiring on February 24, 2016. That period of 180-day exclusivity was not triggered by commercial marketing (ANDA…
…and (k)(6) – and to events in 2006-2007, including precursor legislation and FDA statements, to buttress the company’s argument. “This history compels the conclusion that Congress rejected the option for…
…foreign generic drug manufacturers, or to the facilities that manufacture Active Pharmaceutical Ingredients (many of which are used in generic drug manufacturing). Indeed, we reviewed Warning Letters issued by FDA…
By Kurt R. Karst – It’s that time of year again when FDA-regulated companies need to think about cracking open their checkbooks to pay FDA some pretty heft sums…
…derived complex mixture to be previously approved active moieties for the purpose of determining a subsequent drug’s eligibility for NCE exclusivity: (1) Characterization: The previously approved mixture has been characterized…
…Commission (“FTC”) Consent Order by marketing Relacore and Relacore Extra. Defendants agreed to the FTC Consent Order in 2006 for claims made for a different weight loss product. That Order…
…IV Commitment Letter were relatively minor appeared to have been addressed in the September 2017 version of the guidance. In addition, the MDUFA IV Commitment Letter stated, “FDA will continue…
…Order, the Chief Administrative Law Judge found in his Recommended Decision that: (1) DEA’s provision of the DEA-6 to the expert demonstrated the Agency’s intent that the expert rely on…