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    FDA Discusses RWD, RWE With Industry, Academia

    Industry, academia and US Food and Drug Administration (FDA) officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and real-world evidence (RWE) in the premarket and postmarket settings. Jacqueline Corrigan-Curay, director of CDER’s Office of Medical Policy, kicked off the joint FDA-American Association for Cancer Research meeting to discuss FDA’s framework for using RWE, which was unveiled in December 2018 . The framework is meant to gu...
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    EU Ombudsman Concludes Inquiry on EMA Interactions With Medicine Developers

    The EU ombudsman this week said that it believes that the European Medicines Agency (EMA) should not allow the same experts to provide scientific advice to medicine developers prior to an application and evaluate the same medicine, claiming such overlap runs the risk of damaging impartiality or creating the perception of bias. In response to the comments, following a two-year inquiry into EMA’s interactions with drug developers, EMA said Friday: “Early interactions with...
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    FDA Offers Technical Specifications for Submitting NGS Data on Antivirals

    The US Food and Drug Administration (FDA) on Thursday published a technical specifications document to help sponsors submit next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drugs. The guidance explains how next generation sequencing (NGS) “adds complexity to the resistance analysis process,” which can make it challenging for reviewers “to analyze and validate the sequence information p...
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    Patient Registries May Prove Valuable in Regulatory Decisions, EMA Study Finds

    Although patient registries can be heterogenous in their quality and design, a new study in Drug Safety co-authored by a European Medicines Agency (EMA) official explains how patient registries could provide valuable data for regulatory decisions. The authors explain how such registries can be used when randomized controlled trials are not feasible, such as with some rare diseases, or to meet postmarketing commitments. “For products granted conditional marketing ap...
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    Office of Generic Drugs Explains Research Conducted in First Year of GDUFA II

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Thursday released a report on the two dozen research grants awarded related to complex generics in 2018, as well as the research done in seven other areas, including data analytics and combination products.  Thanks to the second iteration of the Generic Drug User Fee Amendment (GDUFA II), OGD was able to turn its research and scientific activities into 136 new product-specific guidances (PSGs...
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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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    Merck’s Keytruda is First to Add Indications Under TGA’s Provisional Approval Pathway

    Australia’s Therapeutic Goods Administration (TGA) on Wednesday announced that Merck’s Keytruda (pembrolizumab) is the first medicine to have additional indications registered on the Australian Register of Therapeutic Goods (ARTG) via TGA’s provisional approval pathway. Early clinical data allowed for the provisional approval to help treat patients with metastatic colorectal carcinoma, also known as bowel cancer, and other solid tumors with certain types of mutations (d...
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    CBO Finds Major Savings in FDA Provisions of Senate Health Bill

    The Congressional Budget Office (CBO) said Tuesday that the Senate’s bill to lower health care costs will reduce the deficit by about $7.5 billion over 10 years, and the sections with US Food and Drug Administration (FDA) changes will reduce the deficit by about $4.6 billion over the same time period. It remains unknown if or when the bill, known as the Lower Health Care Costs Act , will be taken up for a vote by the full Senate. But the CBO score makes clear that ev...
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    FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

    The US Food and Drug Administration (FDA) recently opened for comment until 26 August a guideline from the International Council for Harmonisation (ICH) on how to collect safety data in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized. The 10-page draft of E19, endorsed by the ICH Assembly on 3 April, is part of efforts to reduce the burden on study participants while facilitating studies that can adva...
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    What Submissions Warrant Exemptions or Waivers From eCTD Requirements? FDA Explains

    The US Food and Drug Administration (FDA) on Monday revised its guidance on the electronic common technical document (eCTD) format to note specific cases where the agency believes a submission should be exempted or granted a waiver. As far as what submission types warrant an exemption from eCTD requirements, FDA points to Type III drug master files (DMFs), which provide information on packaging or packaging materials in support of drug, generic drug or biologic applicat...
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    Why Isn’t Insulin a Complex Generic? PA Representative Asks FDA

    Rep. Mike Kelly (R-PA) sent a letter Tuesday to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless questioning why insulin, which has seen dramatic price increases, is not considered a complex generic drug. If FDA were to consider insulin a complex generic, like some other peptides, drugmakers would only need to submit an abbreviated new drug application (ANDA) to win approval for a copycat product, rather than a 505(b)(2) application, which only pa...
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    Gilead and Novartis Seek to Expand What FDA Considers as Real-World Data and Real-World Evidence

    Just over two months ago, the US Food and Drug Administration (FDA) released draft guidance explaining to drugmakers what constitutes real-world data (RWD) and real-world evidence (RWE) and how to submit such data to the agency. The draft guidance spells out what the agency considers to be an RWD source (i.e. electronic health record data, medical claims or billing data, etc.) and what relevant submissions may include RWE (i.e. single arm trials that use RWE as an ext...