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    Gastroparesis: FDA Revises Draft Guidance

    The US Food and Drug Administration (FDA) on Tuesday updated draft guidance from July 2015 to address public comments and reflect the agency’s current thinking on the development of clinical outcome assessment measures and statistical considerations to assess primary and secondary efficacy endpoints of clinical trials for gastroparesis. The nine-page draft explains: “Until a well-defined and reliable PRO [patient-reported outcome] instrument that measures all the clinic...
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    FDA Drafts Guidance on Developing GnRH Analogues to Treat Advanced Prostate Cancer

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance to help sponsors establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.   GnRH agonists and antagonists are a mainstay for treating patients with prostate cancer, FDA says, noting that it is one of the most common forms of cancer in American men.   “New drug applications for GnRH analogues typically rely, in part, ...
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    Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations

    As hormonal drugs to prevent pregnancy have evolved over the years, the US Food and Drug Administration (FDA) on Thursday drafted new guidance for drug developers on the recommendations for clinical trials designed to establish clinical effectiveness and safety for such products. In terms of key considerations for clinical trial design features, the six-page draft begins by explaining the recommended enrollment criteria for nonpregnant, premenopausal woman in trials, wh...
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    FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

    The US Food and Drug Administration (FDA) on Thursday released revised draft guidance to help keep sponsors informed on the data and model requirements for population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. Since the original population PK guidance was published in 1999, FDA says the number of applications relevant for population PK analysis has increased and, “The sophistication and reliability of pop...
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    EC Issues Additional Guidance on Device Vigilance System

    While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.   The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (U...
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    New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with a new product’s FDA-approved quality and labeling requirements.   Background   New and generic drug applicants and drug master file holders must ensure that a drug product or substance complies with applicable standards in the US...
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    FDA Drafts Guidance on Heart Failure Treatment Endpoints

    As heart failure afflicts 6.5 million in the US, the Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s current thinking on developing drugs to treat heart failure. While noting that there are no effective treatments for heart failure with preserved ejection fraction (HFpEF), which represents about 50% of heart failure cases, FDA says up front that the 7-page draft has two purposes: to make clear that an effect on symptoms or physical...
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    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...
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    FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

    A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product. The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft gui...
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    FDA Finalizes Guidance on Convenience Kit UDI Marking

    The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits. The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall ou...
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    CDRH Drafts Guidance on Quantitative Imaging

    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday. CDRH’s proposed recommendations cover the device’s functional description, technical performance assessment and labeling/user information. For devices that include quantitative imaging functions, th...
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    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...