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Guide on New Dietary Ingredient Notifications
[120 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance entitled “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” |
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05/20/2022
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Device Cybersecurity Clarifications in FDA Webinar
[157 Words]
[ Price : $8.95]
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| FDA announces a 6/14 Webinar to share information and answer questions about its recent draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” |
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05/20/2022
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House Commerce Republicans Probe China Trials
[298 Words]
[ Price : $8.95]
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| House Energy and Commerce Committee Republican leaders ask FDA commissioner Robert Califf to answer questions about a growing trend for clinical trials to rely solely on enrollment of patients from a single country, particularly China, and the history of fabricated data in clinical trials conducted in China. |
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05/20/2022
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Dietary Supplement NDI Enforcement Discretion
[2844 Words]
[ Price : $8.95]
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| FDA publishes a draft guidance on possible enforcement discretion so dietary supplement companies can correct past failures to submit required new dietary ingredient premarket notifications. |
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05/19/2022
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FDA Moving Toward Emerging Technology Regs: Kopcha
[2750 Words]
[ Price : $8.95]
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| CDER Office of Pharmaceutical Quality director Michael Kopcha says the agency is working on regulations to help companies become more comfortable with advanced manufacturing technologies. |
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05/19/2022
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CDRH Device Sterility Master File Pilot
[340 Words]
[ Price : $8.95]
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| CDRH announces a new “510(k) Sterility Change Master File Pilot Program” that is intended to give interested companies that terminally sterilize single-use devices (sterilization providers) using certain sterilization methods a pathway to submit a master file for the Center’s review. |
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05/19/2022
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Drug Shortage Risk Management Guidance
[2670 Words]
[ Price : $8.95]
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| FDA publishes a draft guidance to help develop, maintain, and implement risk management plans to assist in preventing human drug shortages. |
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05/19/2022
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FDA Enterprise Modernization Plan Explained
[2825 Words]
[ Price : $8.95]
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| FDA principal deputy commissioner Janet Woodcock explains the components of the agency’s new Enterprise Modernization Action Plan. |
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05/19/2022
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