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  • Regulatory NewsRegulatory News

    FDA Replaces Withdrawn Biosimilar Guidance With New One on Quality-Related Considerations

    A week after finalizing guidance on developing interchangeable biosimilars, the US Food and Drug Administration (FDA) has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product. The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft gui...
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    FDA Finalizes Guidance on Convenience Kit UDI Marking

    The US Food and Drug Administration (FDA) issued final guidance Thursday to provide medical device manufacturers clarifications on unique device identification (UDI) marking policies for convenience kits. The guidance finalized the 2016 draft version of the document, developed by FDA’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research. Combination products and in vitro diagnostics subject to labeling requirements fall ou...
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    CDRH Drafts Guidance on Quantitative Imaging

    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday. CDRH’s proposed recommendations cover the device’s functional description, technical performance assessment and labeling/user information. For devices that include quantitative imaging functions, th...
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    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...
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    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
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    Industry Calls for Changes in Two REMS Guidances

    Industry groups representing the pharmaceutical, biotechnology and generic drug industries are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on risk evaluation and mitigation strategies (REMS).   The draft guidances , released for comment in January, detail a framework for companies to develop an assessment plan for their REMS programs and provide recommendations for surveying patient and health care provider knowledge of REMS...
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    Patient Groups, Industry Seek Changes to Rare Disease Drug Guidance

    Patient groups, drugmakers and other organizations are calling for changes to the US Food and Drug Administration’s (FDA) recently revised draft guidance on developing drugs to treat rare diseases.   The 24-page draft guidance was revised last February after first being published in 2015. The revision included updates to the agency’s approach to natural history studies, a discussion of issues for evaluating biomarkers for consideration as surrogate endpoints and a ne...
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    When a REMS is Necessary: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2016 detailing the factors that the agency uses to determine whether a risk evaluation and mitigation strategy (REMS) is necessary for a drug. As defined by the guidance, a REMS is a required risk management plan that can include one or more elements to ensure that the benefits of a drug outweigh its risks. Such elements can include a medication guide, a package insert or a communication plan ...
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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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    FDA Finalizes Guidance on Pediatric Information in Drug Labels

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on the content and placement of pediatric information within the labeling of drugs and biologics.   “The goal of this guidance is to provide recommendations to help ensure that information on the use of prescription drugs in pediatric populations (whether positive, negative, or inconclusive) is consistently placed in the proper sections and subsections within labeling so that the information is c...
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    FDA Draft Guidance on Patient Experience Data Incomplete, Critics Argue

    Industry group BIO, the National Association for Rare Disorders (NORD) and the National Center for Health Research (NCHR) called for clarification on how regulators will use draft guidances proposed by external stakeholders on patient experience data. The comments on the US Food and Drug Administration (FDA) draft guidance from December 2018 on developing and submitting proposed draft guidances related to patient experience data showed some consensus around including ...
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    FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the nonclinical studies drugmakers should conduct when developing products to treat severely debilitating or life-threatening hematologic disorders (SDLTHDs).   FDA classifies SDLTHDs as hematologic conditions that cause shorter life expectancy or greatly diminished quality of life even with available treatments.   FDA notes that the guidance does not apply to hematologic cancers and covers...