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    MDUFA V negotiations press on with breakdown over TPLC proposal

    In the latest negotiation session for the upcoming Medical Device User Fee Amendments (MDUFA V) program, the US Food and Drug Administration (FDA) and industry groups diverged over the agency’s ambitions for the next five-year program and the industry’s desire to lock-in gains from past programs.   TPLC Advisory Program   During the previous meeting on 7 April, FDA presented its vision for a Total Product Lifecycle (TPLC) Advisory Program (TAP) to a skeptical indus...
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    FDA finalizes guidance on studying CNS metastases in cancer trials

    A final guidance document from the US Food and Drug Association (FDA) provides recommendations for drug developers on how best to evaluate the safety and efficacy of cancer drugs in patients with central nervous system (CNS) metastases. The document finalizes a draft guidance issued in August 2020.   "There are few effective treatments for patients with central nervous system (CNS) metastases – a type of cancer that has spread from the original tumor to the CNS and is ...
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    FDA finalizes long-awaited UDI guidance

    The US Food and Drug Administration (FDA) on Tuesday finalized its guidance on the form and content requirements for unique device identifiers (UDI), nearly five years after releasing its draft guidance and eight years after issuing the UDI final rule.   FDA said the guidance is intended to describe “the requirements for, and FDA’s recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs me...
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    PIC/S finalizes GMP data integrity guidance

    This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.   When authorities inspect facilities of manufacturers and distributors of active pharmaceutical ingredients to ensure good manufacturing practice and good distribution practice (GMP/GDP) compliance, “The effectiveness of these inspection processes...
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    DIA: Woodcock, other top officials tout benefits of master protocols, want momentum to continue post-COVID

    Top officials from the US Food and Drug Administration (FDA) exhort the benefits of master protocols and hope the momentum of using these protocols continues in the post-COVID-19 era. Officials also say the pandemic has not dampened the enthusiasm for gene therapy development as the agency continues to receive a healthy number of investigational new drug applications (INDs) for these therapies.   These were some of the learnings imparted by agency officials in discussi...
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    FDA issues draft guidance for transdermal adhesion systems

    The US Food and Drug Administration has issued new draft guidance for clinical trials examining the adhesion performance of transdermal and topical delivery systems (collectively, TDS) for new drug applications.   Surface area is an important variable in determining the amount of drug delivered through a TDS; adhesion performance can affect both safety and effectiveness of TDS products because adhesion failures can result in reduced effectiveness caused by suboptimal d...
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    House Appropriations advances FDA funding bill

    The House Committee on Appropriations on Wednesday advanced legislation that would provide the US Food and Drug Administration (FDA) with $3.45 billion in budget authority for FY2022, a $257 million increase over the FY2021 enacted level.   In a voice vote, the committee moved to send the $26.55 billion bill to the full House for consideration, less than a week after the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee’s m...
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    FDA issues final guidance on providing regulatory submissions in alternate electronic formats

    The US Food and Drug Administration on Thursday issued a final guidance to assist sponsors in using alternate electronic formats for submitting applications that are exempt from electronic common technical document (eCTD) filing requirements.   The guidance contains few changes from the draft issued in March 2020. (RELATED: FDA Drafts Guidance on Alternate Electronic Formats, Announces Support for New Data Standards , Regulatory Focus, 10 March 2020 ). In its fina...
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    FDA studies: No post-ingestion NDMA from ranitidine

    An editorial that accompanied two recent studies examining the potential for nitrosamine formation from the antacid ranitidine welcomed reassuring news provided by the US Food and Drug Administration- (FDA-) led investigations.   The two FDA-led studies taken together “should serve to alleviate much of the previous concern about [ N -nitrosodimethylamine] production of dimethylamine drugs in the human body,” according to C. Michael White of the School of Pharmacy at th...
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    FDA focuses on efforts made to avert drug shortages in 2020

    New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...
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    FDA releases first Cures Act report on patient experience data in regulatory decision-making

    The US Food and Drug Administration (FDA) has published its first report on how it uses patient experience data in regulatory decision-making.   As part of the 21st Century Cures Act of 2016 , FDA is required to publish patient data assessment reports in 2021, 2026, and 2031. The agency contracted Eastern Research Group, Inc. to conduct the assessment and publish the report for 2021.   When assessing how FDA uses the experience of patients in their decision-making...
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    FDA gives generics updates at DIA town hall

    Officials at the US Food and Drug Administration (FDA) addressed plans to prioritize on-site inspections and gave updates regarding certain new drug applications during a generics-focused virtual town hall convened by the Drug Information Association (DIA) as part of its virtual annual meeting. During the session, regulators also shared post-pandemic learnings, including the importance of international collaborations for generic drug development.   The session inclu...