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    OGD Explains How it Reviews and Conducts Pre-ANDA Meetings

    In a newly issued manual of policies and procedures (MAPP), the US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) explains how it evaluates and conducts two types of meetings under its pre-abbreviated new drug application (ANDA) program.   In the eight-page MAPP, the office explains its criteria for granting or denying product development and pre-submission pre-ANDA meetings. The MAPP also provides timeframes for how the agency conducts those meetin...
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    Population Pharmacokinetics: Drugmakers Seek Clarity and Additions to Revised FDA Guidance

    About a dozen drugmakers and industry groups recently offered their opinions on a revised US Food and Drug Administration (FDA) draft guidance related to population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. The comments largely seek specific tweaks to the 23-page revised draft, which was released in July , although some of the comments also seek further clarity and new additions to the guidance. Indu...
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    FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

    The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada. The collaboration, dubbed Project Orbis , was launched with FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai's Lenvima (lenvatinib) in combination with Merck's Keytruda (pembrolizumab) for the tre...
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    CDRH Warns Idaho Wheelchair Manufacturer for Unapproved Modifications

    The videos at 21 st Century Scientific’s website wheelchairs.com show people taking their wheelchairs off-road, in the sand and at high speeds. But the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told the Idaho-based company in a warning letter posted Tuesday that these modifications to their wheelchairs were never approved by the agency. “Use on these terrains and functions that enable the device to lift the user, tilt the...
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    MHRA Updates on Biologics Pharmacopoeial Quality Strategy

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday provided an update on its strategy for pharmacopoeial quality standards for biological medicines.   The agency's five-year strategy for pharmacopoeial quality standards for biologics was released in 2017 following a public consultation earlier that year.   For its 2019 update, MHRA said it reviewed its strategy and work program and made editorial changes to the strategy document to br...
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    NASEM, Royal Society Consult on Human Genome Editing Framework

    The US National Academies of Sciences, Engineering and Medicine (NASEM) and the UK's Royal Society issued a call for evidence on human germline genome editing as the two scientific bodies prepare to host an international commission to develop a framework for the scientific, medical, regulatory and ethical requirements necessary for such applications.   The commission, which met for the first time in August in Washington, DC, will consider submissions to the consultat...
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    FDA Awards $4M in Grants to Support Development of COAs

    As part of the US Food and Drug Administration’s (FDA) work to develop publicly available Clinical Outcome Assessments (COAs), the agency awarded three grants to researchers at Albert Einstein College of Medicine, Duke University and Northwestern University. The grants, which total about $4 million, are meant to help collect patient input to inform the selection of clinical outcomes and how data is collected. “If methodologically sound data collection tools are devel...
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    FDA Explains Plans for New Pharmaceutical Quality Assessment System

    As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics . The authors describe KASA as a new s...
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    FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

    The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. Among th...
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    Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

    The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs, Ibrance (palbociclib) from Pfizer, Novartis' Kisqali (ribociclib) and Lilly's Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death. “We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall bene...
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    FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

    Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. FDA’s decision on the label followed a push from Sprout to remove the warning entirely. Sprout touted newly released...
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    EMA, FDA Begin Reviewing Heartburn Medicines for Carcinogen

    Following its investigation into an impurity called N-nitrosodimethylamine (NDMA) in blood pressure medicines, the European Medicines Agency (EMA) on Friday said that, at the request of the European Commission, it’s beginning a review of ranitidine medicines after tests showed that some contained the impurity. NDMA is classified as a substance that could cause cancer on the basis of animal studies, although EMA explains how it is present in some foods and in water suppl...