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  • Regulatory NewsRegulatory News

    FDA Warns Ocular Therapeutix Over Failure to Comply With Postapproval Requirements

    Ocular Therapeutix drew a US Food and Drug Administration (FDA) warning letter for failing to comply with post-approval study requirements (PAS) set as part of its ReSure Sealant’s conditional approval. The warning letter, dated October 2018, cites the company’s failure to collect any data for its FDA-approved protocol—identified as a Device Exposure Registry (DER) study—as part of the PAS requirements in the 4.5 years since the conditional approval. Ocular Therapeutix’...
  • Regulatory NewsRegulatory News

    FDA Flags Higher Death Rates Linked to Use of Abiomed Heart Pump in Post-approval Study

    A temporary heart pump manufactured by Massachusetts-based Abiomed prompted a US Food and Drug Administration letter to health care providers on Monday over an increased rate of mortality. The letter cites interim results from Abiomed’s January report on a post approval study (PAS) that was mandated by the agency as a condition for the 2017 FDA approval of the Abiomed Impella RP System. “A total of 44 out of 60 patients (73.3%) survived to 30 days post device explant...
  • Regulatory NewsRegulatory News

    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (24 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Draft Guidance on Postapproval Manufacturing Changes China Food and Drug Administration (CFDA) is seeking feedback on its guidance on postapproval manufacturing revisions. The draft texts propose three tiers of changes to production processes and detail the regulatory steps companies need to take in each circumstance. Echoing draft guidance posted by the US...
  • Regulatory NewsRegulatory News

    CDRH Plots Creation of New 'Super Office,' Alternative 510(k) Pathway

    Jeff Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) told attendees at the final session at AdvaMed’s MedTech conference in San Jose, California, that his center is plotting the creation of a new "super office." The so-called "Total Product Life Cycle 'Super' Office" will integrate premarket, postmarket surveillance and quality-compliance functions, Shuren said, noting it will be "a big deal." The o...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

    As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report. "Under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities, o...
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    FDA Drug Approvals on Limited Evidence: Follow-Ups Lacking, Study Finds

    For drugs approved by the US Food and Drug Administration (FDA) based on limited evidence, a recent study published in the British Medical Journal found “noticeable variability” in the degree to which novel drugs were studied in the postmarket period. The authors, including Yale University professors Harlan Krumholz and Joe Ross, urged FDA to take a cautious approach in increasing its reliance on surrogate markers, smaller and shorter trials, and evidence derived ...
  • Regulatory NewsRegulatory News

    Postapproval CMC Changes: FDA Updates Guidance

    Drug and biologics manufacturers looking to implement a chemistry, manufacturing and controls (CMC) postapproval change through the use of a comparability protocol (CP) should take note of an updated US Food and Drug Administration (FDA) draft guidance released Tuesday. The revised draft provides recommendations to drug manufacturers on implementing CMC postapproval change(s) through the use of a CP. Companies that fall within the scope of this guidance will not have to...
  • FDA Releases Draft Guidance for Industry on Safety Data Collection

    The US Food and Drug Administration (FDA) released new draft guidance for industry entitled Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations on 9 February. The document provides guidance on how to determine the amounts and types of safety data to collect in trials conducted late in the premarketing process or after a product's approval. The guidance will also allow sponsors of clinical trials to...