• 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 outlines process for communicating record requests findings

    The US Food and Drug Administration (FDA) says it has put in place an interim process to communicate issues identified during record reviews done in lieu of or in advance of preapproval inspections with drugmakers and consider their responses before taking action on an application.   The agency says the interim process will continue throughout the COVID-19 public health emergency and may be extended to other drug inspection programs, including routine surveillance insp...
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    Inspections: GAO calls on FDA to plan for backlog, review alternatives

    In a nearly 350-page report to Congress on the federal government’s COVID-19 response, the Government Accountability Office (GAO) calls on the US Food and Drug Administration (FDA) to review its inspections approach and come up with a plan to address its looming backlog.   Pandemic inspection alternatives   In the early days of the pandemic, FDA halted non-mission-critical foreign and domestic inspections and relied on alternative tools, such as inspection reports ...
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    FDA details review timelines as facility assessment-related CRLs pile up

    In guidance released Monday, the US Food and Drug Administration (FDA) provides the timelines it will stick to when reviewing responses to complete response letters (CRLs) for drugs and biologics when a facility assessment or inspection is required in order for the agency to make a decision on the application.   FDA’s ability to conduct on-site inspections has been dramatically curtailed amid the COVID-19 pandemic due to public health concerns and travel restrictions. ...
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    FDA issues pandemic inspections FAQ guidance

    The US Food and Drug Administration (FDA) on Wednesday issued an immediately effective frequently asked questions guidance  explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.   Inspections   For the time being, FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval an...
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    FDA looks to resume domestic inspections this month

    Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections beginning the week of 20 July 2020.   As a safety measure, FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future.   The announcement comes nearly two months after the agency said it will implement a phased approach to restartin...
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    OND Reorganization Moves Forward

    The US Food and Drug Administration said Thursday that the planned reorganization of its Office of New Drugs (OND) will move forward thanks to Congressional approval, including changes to its Office of Translational Sciences (OTS) and the Office of Pharmaceutical Quality (OPQ). The changes will create offices for interrelated disease areas and divisions with clearer and more focused expertise, FDA said , noting the number of OND offices that oversee its review division...
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    Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

    As the US Food and Drug Administration (FDA) explores plans to lower the cost of pharmaceuticals with imports from Canada and elsewhere, Sen. Chuck Grassley (R-IA) is calling on the agency to perform more unannounced inspections of foreign facilities. Thanks to recent media coverage (on  China and tainted blood pressure medicines  and another article on  generic drug manufacturing ) as well as a controversial new book on the US reliance on foreign-made generic medicin...
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    FDA Drafts Guidance on Inspections of Medical Device Establishments

    The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA has updated processes and standards for uniformity within and across inspections other than for-cause and to establish a standard timeframe for such inspections of device establishments. The uniformity in FDA investigators’ approaches to these inspections “may inform firms’...
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    Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews

    Industry experts raised questions around the US Food and Drug Administration (FDA) recent proposal that would allow FDA to inspect manufacturing facilities prior to granting de novo classification requests. The proposal is part of the 76-page proposed rule FDA’s Center for Devices and Radiological Health (CDRH) set forth last December. The proposed rule addresses the lack of de novo-specific regulation that puts the program at a disadvantage compared to the traditiona...
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    FDA Touts Quality Office’s Achievements in 2018

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Thursday released its 2018 annual report touting its accomplishments in a year that saw record numbers of new and generic drug approvals.   OPQ is the office responsible for quality assessments for investigational new drug applications (INDs) and all marketing applications reviewed by the Center for Drug Evaluation and Research (CDER), including new drug applications (NDAs), abbreviat...
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    FDA Warns Two Drugmakers for GMP Violations

    The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...