• FDA’s OPQ reports on drug quality efforts in 2020

    The office tasked with overseeing pharmaceutical quality within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its annual report for 2020 on Thursday, highlighting its effort in a year marked by the COVID-19 pandemic.   In its previous annual report, the Office of Pharmaceutical Quality (OPQ) touted its participation in nearly one third of the preapproval inspections FDA carried out in 2019. For 2020, OPQ instead foc...
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    FDA eyes adaptive designs for BE studies impacted by COVID-19

    The US Food and Drug Administration (FDA) is looking to adaptive designs to salvage in vivo bioequivalence (BE) studies that have been disrupted by the COVID-19 pandemic.   FDA acknowledged the impact that the public health emergency could have on BE studies early in the pandemic and in April 2020 the agency created a webpage with information for abbreviated new drug application (ANDA) sponsors noting that protocol revisions may be required for studies that are inter...
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    A look at FDA’s data on priority and competitive generics

    Three years into the second Generic Drug User Fee Amendments (GDUFA II) program, the US Food and Drug Administration (FDA) has seen the number of priority and competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) approved or under review rise as generic drugmakers continue to pursue both designations. The FDA Reauthorization Act of 2017 (FDARA), which reauthorized GDUFA for five years, includes provisions to shorten the reviews of certain ANDAs...
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    FDA issues guidance on resuming or initiating BE studies amid pandemic

    New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic drugs during the COVID-19 pandemic.   The guidance, aimed at ensuring participant and study staff safety, calls on generic drug developers to carefully consider protocols for resuming or initiating BE studies and to take steps to ensure the scientific validity of data generated from studies impacted by ...
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    HHS pushes through last-minute policies impacting FDA

    With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.   Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-cou...
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    PDUFA VII: Negotiations continue with focus on regulatory decision tools, digital health and CMC

    The US Food and Drug Administration (FDA) on Monday released its latest batch of meeting summaries in the ongoing negotiations with the pharmaceutical industry that will shape the next Prescription Drug User Fee Act (PDUFA VII) program.   The meetings, all of which took place in October, shed light on the programs and priorities FDA and industry are pursuing as they hammer out an agreement over the next five years of the agency’s multibillion-dollar drug review pro...
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    HHS moves to end FDA’s unapproved drugs initiative

    Following an announcement by outgoing President Donald Trump on Friday, the Department of Health and Human Services (HHS) is moving to end the Food and Drug Administration’s (FDA) unapproved drugs initiative, which the agency claims has led to increased drug prices for some older drugs. FDA’s unapproved drugs initiative can be traced back more than a decade to the agency’s 2006 compliance policy guide (CPG) on marketed drugs without approved new drug applications (NDAs...
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    FDA launches online orphan submissions portal

    The US Food and Drug Administration (FDA) on Monday launched a new cloud-based submission portal for orphan drug designation requests, shifting away from the current paper and CD-based submission process. The new portal, first announced in January, is part of the agency’s orphan drug technology modernization effort and fits in with its broader technology modernization plans. The shift to electronic submissions follows a decade of increasing orphan drug designation reques...
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    FDA issues 34 new and revised product-specific guidances

    In its latest quarterly release of product-specific guidances meant to promote the development of generic drugs, the US Food and Drug Administration (FDA) on Wednesday posted 13 new and 21 revised draft guidances, bringing the total number of such guidances released by the agency to 1,974.   The guidances are intended to foster generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a refe...
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    FDA publishes list of essential medicines, devices

    To comply with a recent executive order, the US Food and Drug Administration (FDA) on Friday released a list of more than 300 essential drugs and medical devices that will serve as a basis for prioritized federal procurement of those products from domestic sources.   The list was developed in response to President Donald Trump’s “Buy American” executive order , issued in August, aimed at boosting domestic production of drugs and medical devices. (RELATED: Trump’s ...
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    FDA approves fewer generics in FY2020, ending record streak

    After four straight years of posting record numbers of abbreviated new drug application (ANDA) approvals, the US Food and Drug Administration (FDA) has broken its streak, approving 22% fewer generic drugs in FY2020 than it did in FY2019.   In FY2020, FDA approved a total of 909 ANDAs, 737 full approvals and 172 tentative approvals, compared to a record 1,171 ANDAs in FY2019. Complete responses also declined to 2,010 compared to 2,310 in FY2019. (RELATED: Another reco...
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    FDA orphan drug updates at NORD Summit

    Officials from the US Food and Drug Administration (FDA) provided updates on the agency’s efforts to support the development of medical products for rare diseases at the National Organization for Rare Disorders (NORD) Summit this week.   In his keynote address on Thursday, FDA Commissioner Stephen Hahn said that FDA had already approved 51 orphan indications through July of this year and acknowledged that the agency’s Office of Orphan Products Development (OOPD) has se...