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    Drugmakers Seek Clarity on Two FDA Labeling Guidances

    Drugmakers and industry groups are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on product labeling, one covering instructions for use (IFU) for drugs, biologics and combination products and the other providing recommendations on drug abuse and dependence labeling.   IFU Patient Labeling   In its comments, the Combination Products Coalition (CPC) said it appreciates the aim of the guidance, but requested the agency clari...
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    FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

    The US Food and Drug Administration (FDA) said Monday that an inspection of an outsourcing facility uncovered information about 4,202 adverse events linked to compounded hormone pellets that had never been reported to the agency. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement that the mishap highlights the need for compounders of drugs and other affiliated organizations to report adverse events promptly.   “The adver...
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    FDA Developing Guidance on Real-World Data Quality Issues, Officials Say

    As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products w...
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    Novartis Makes New Data Integrity Commitment

    Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on Monday that the company will be more proactive in reporting data integrity issues to the US Food and Drug Administration (FDA). “We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible all...
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    FDA Gives Drugmakers More Time to Join Quality Metrics Feedback Program

    The US Food and Drug Administration (FDA) on Friday reopened the submission period for its Quality Metrics Feedback Program for another 120 days after the one-year submission window closed in June.   The feedback program is one of two voluntary quality metrics pilot programs FDA announced in June 2018 and is intended to encourage new drug application (NDA) holders to request Type C Formal Meetings and abbreviated new drug application (ANDA) to submit pre-ANDA meeting...
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    FDA Adopts Units of Measure Standard for Regulatory Submissions

    The US Food and Drug Administration (FDA) on Friday announced its support for the latest set of Unified Code for Units of Measure (UCUM) codes for use in electronic submissions for drugs and biologics.   “UCUM offers a single coding system for units of measure that does not contain ambiguities amongst electronic communication, and assigns a concise semantics to each defined unit,” FDA writes.   With the notice, FDA says it wants drugmakers to use UCUM coding for dr...
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    EMA Begins Review of Skin Cancer Data for Patients Using Picato

    EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) on Friday announced that it’s begun reviewing data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, which is a skin condition caused by excessive sun exposure. The review, which will run until January 2020, was triggered by data from several studies showing a higher number of skin cancer cases including cases of squamous cell carcinoma in patients using Picato, EMA ...
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    De Novo Requests: FDA Finalizes Three Guidances

    The US Food and Drug Administration (FDA) on Friday finalized three guidance documents related to de novo classification requests for medical devices. Devices using the de novo classification process are those for which there is no predicate device to rely on, and devices granted a de novo request can serve as a predicate device for a later 510(k) submission. So far in 2019, CDRH has granted 15 de novo requests, which compares with 44 requests granted in 2018 and 31 in ...
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    Humanitarian Device Exemptions: FDA Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on the Humanitarian Device Exemption (HDE) program, reflecting changes made by the 21 st Century Cures Act and further explaining the criteria to determine “probable benefit” related to its decision-making process for humanitarian use devices (HUDs). HUDs are medical devices intended to help treat or diagnose diseases or conditions that affect or are manifested in not more than 8,000 individual...
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    Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations

    Ahead of a planned draft guidance on assessing the benefits and risks of new weight-loss devices, the US Food and Drug Administration (FDA) on Thursday circulated a discussion paper to gather feedback on some of concepts the agency is considering for the guidance.   “Obesity is a major public health epidemic in the US and is associated with many health problems such as heart disease, diabetes and stroke. Having a variety of weight-loss treatment options available, incl...
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    FDA Offers Advice on Extrapolating Efficacy of Seizure Drugs from Adults to Children

    The US Food and Drug Administration (FDA) on Thursday finalized guidance providing recommendations for developing drugs to treat pediatric patients with partial onset seizures (POS) by extrapolating efficacy data from drugs approved to treat adult patients with the condition.   The three-page guidance finalizes a draft version released for comment in February 2018. Most notably, the final guidance extends the age range of patients for whom efficacy data can be extrap...
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    New Report Compares FDA Quality System Requirements With ISO 13485:2016

    The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...