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  • Regulatory NewsRegulatory News

    180-Day Exclusivity for Generics: FDA Releases Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday put out new draft guidance consisting of 45 questions and answers on the 180 days of exclusivity provided to some generic drugs. Background The statute provides an incentive and a reward to generic drug applicants that expose themselves to the risk of patent litigation. It does so by granting a 180-day period of exclusivity for an abbreviated new drug application (ANDA)  applicant that is first to file a substantial...
  • Regulatory NewsRegulatory News

    What's a ‘High Priority’ Drug? Generic Drug Industry Offers Ideas to FDA

    The generic pharmaceutical sector is calling on the US Food and Drug Administration (FDA) to make changes to a proposed policy that would make it easier for regulators to prioritize the review of some new generic drug products for which there is no previously approved generic. Background In August 2014, FDA released a new policy that proposed a major change to the agency's generic drug review policies. Traditionally, FDA has mostly operated on a first-to-file system in ...
  • Regulatory NewsRegulatory News

    How Should FDA Prioritize the Review of Important New Generic Drugs? Agency Wants to Know

    How should the US Food and Drug Administration (FDA) define the term "first-to-file" when it comes to approving new generic drug products? While the question seems small, at stake is nothing less than potentially billions in savings for consumers and the US government. Background In 2012, Congress pushed through a major piece of legislation to overhaul various aspects of how FDA regulates products. The law, the Food and Drug Administration Safety and Innovation Act (FD...
  • Regulatory NewsRegulatory News

    Are New Policies Needed to Help Regulate Generic Drugs? FDA Wants to Know

    US drug regulators are getting ready to take a close look at the regulation of generic drugs, including new policies recently proposed by the US Food and Drug Administration (FDA) and areas that could stand to benefit from additional regulation. Background In a new Federal Register notice posted on 18 August 2014, FDA said it will soon hold a meeting to focus on the implementation of the Generic Drug User Fee Act (GDUFA), a program passed as part of the 2012 Food and...
  • Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex

    Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...
  • FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos

    • 23 October 2012
    The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion. The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manu...
  • FDA Approves Generic Lexapro

    The US Food and Drug Administration (FDA) today approved Israeli pharmaceutical manufacturer Teva Pharmaceutical Industries to legally market generic Lexapro for depression and generalized anxiety disorder in adults. Teva has been granted 180 days of marketing exclusivity, during which FDA is not allowed to approve any other generic version of Lexapro, originally manufactured by Forest Laboratories. Teva's Abbreviated New Drug Application (ANDA) for Lexapro was original...
  • Reps. Waxman, Rush Introduce Bill to Stop 'Pay-For-Delay' Settlements

    • 13 February 2012
    A bill introduced by Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) on 9 February would end so-called "pay-for-delay" settlements used by pharmaceutical companies to delay competition from generic competitors. The bill, Protecting Consumer Access to Generic Drugs Act of 2012 (H.R. 3995) , declares it "unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which (1) an [Abbreviated ...