• Regulatory NewsRegulatory News

    FDA updates guidance on covariate treatment in clinical trials

    In a revised draft guidance, the US Food and Drug Administration (FDA) has clarified how drug developers should adjust for covariates in certain clinical trials.   The revision provides “more detailed recommendations for the use of linear models for covariate adjustment and also includes recommendations for covariate adjustment using nonlinear models,” according to FDA’s Federal Register notice of the newly revised draft.   The updates to the April 2019 draft l...
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    FDA finalizes brain-computer interface guidance, issues draft for glycemic control devices

    The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for the magnetic resonance imaging environment, clinical studies for devices to improve glycemic control and premarket notification submissions for peripheral atherectomy devices.   The four documents, one in draft and three in final form, were part of a larger swath of guidance...
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    FDA pushes back deadline for removal of legacy identifiers to 2023

    After receiving pushback from industry, the US Food and Drug Administration (FDA) on Thursday said it will give medical device makers two more years to remove legacy identification numbers from their product labels and packages.   Under FDA’s 2013 unique device identification (UDI) final rule, medical device labels and packages are required to bear a UDI according to the schedule set in the final rule, with some exceptions and alternatives for certain devices. The UDI ...
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    FDA releases batch of 21 product-specific guidances

    The US Food and Drug Administration (FDA) on Wednesday issued 13 new and eight revised draft product-specific guidances intended to facilitate the development of generic drugs.   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 reference listed drug (RLD). FDA’s current count of product-specific guidances sits at 1,896 with this latest release....
  • RoundupsRoundups

    FDA Approvals Roundup: Zynrelef, Empaveli, Ingrezza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Zynrelef cleared as long-acting combination therapy for postoperative pain Heron’s Zynrelef (bupivacaine and meloxicam) extended-release solution has been approved as a postsurgical analgesic lasting for up to 72 hours in adults who have undergone bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. The approval is for u...
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    New guidance for developers of CINV prophylaxis shifts endpoints

    New draft guidance from the US Food and Drug Administration (FDA) updates which endpoint assessments and evidence are needed to show efficacy for medicines that treat chemotherapy-induced nausea and vomiting (CINV).   The guidance shifts away from the previous approach, where sponsors would choose a primary efficacy endpoint of complete response, which was defined as no vomiting and no use of rescue antiemetic medication. Direct evaluation of nausea severity and freque...
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    FDA clarifies potential actions when onsite inspections are infeasible

    The US Food and Drug Administration (FDA) on 17 May revised its question-and-answer guidance on inspections during the COVID-19 pandemic to clarify the regulatory actions it plans to take when it cannot conduct an onsite inspection of a facility.   FDA announced that while the pandemic continues to restrict onsite inspections, the agency “intends to continue using alternative tools to evaluate facilities.” FDA continues to conduct onsite inspections for those products ...
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    FDA: Flexibility okay for gaps in gene therapy trials

    The US Food and Drug Administration (FDA) is not amenable to changing study endpoints or sample sizes for gene therapy clinical trials but is encouraging sponsors to fill in gaps in data collection with telemedicine and remote visits.   Wilson Bryan, director of the FDA’s Office of Tissues and Advanced Therapies (OTAT) in FDA’s Center for Biologics Evaluation and Research, told a 12 May meeting of the American Society of Gene and Cell Therapy that the pandemic is promp...
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    FDA issues new COVID-19 master protocol guidance

    A new guidance from the US Food and Drug Administration (FDA) addresses how master protocols can be used in developing drugs to treat or prevent COVID-19.   “To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials,” said acting FDA Commissioner Janet Woodcock in announcing the new guidance. “Master protocols that are well designed and executed can acce...
  • OSE's annual report details Sentinel efforts during COVID pandemic

    The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.   The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).   However, OSE also continued its efforts in other a...
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    FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices

    High field strength magnets in some consumer electronic devices may trigger “magnet mode” in certain implanted medical devices such as pacemakers and cardiac defibrillators, the US Food and Drug Administration said on Thursday.   Many implanted electronic medical devices feature a magnet mode to allow the safe operation of the device during medical procedures such as an MRI scan. While in magnet mode normal device operations are suspended and the mode is typically enga...
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    FDA calls for input on peptide evaluation

    The US Food and Drug Administration (FDA) is seeking comments on strategies for the pharmacological assessment of peptides, small polymers made up of 40 or fewer amino acids.   “For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides, as well as the effects of peptides on cardiac electrophysiology,” wrot...