Generic Celebrex Dispute Shows Hatch-Waxman’s Legal Wrath
Executive Summary
Ongoing battle over 180-day exclusivity shows just how complex life under the 1984 amendments to the FD&C Act can get.
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Celebrex Reissue Patent Reawakens Generic Litigation
Pfizer sues five generic firms alleging their celecoxib ANDAs infringe a reissued method-of-use patent, which protects the blockbuster COX-2 inhibitor until December 2015, 18 months longer than had been expected.
Rare Diseases: CBER Looks To ‘Lean Into’ Accelerated Approval, Align More With CDER
US FDA biologics center officials spoke about their efforts to increase collaboration and harmonization with the drugs center, and to internally involve more review disciplines in evaluating biomarker evidence, during a Reagan-Udall Foundation meeting that weighed potential use of accelerated approval for neuronopathic mucopolysaccharidoses disorders.
RWE: Non-Interventional Studies Must Be Able To Distinguish A True Treatment Effect, US FDA Says
Agency describes a host of issues sponsors should consider and address before pursuing observational or case-control studies to support regulatory decision-making on drug efficacy or safety; new draft guidance was issued under the FDA’s Real-World Evidence program.