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01 NOVEMBER 2016GUIDANCE FOR INDUSTRY REPORTING OF THERAPEUTIC PRODUCT DEFECTS AND RECALL OF THERAPEUTIC PRODUCTSGuidance for Industry Reporting and Recall of Defective Therapeutic Products01 November
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Guidance for industry is needed by various stakeholders including:
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- Small business owners: It can provide valuable guidance and information for small businesses that may lack resources or expertise in certain areas.
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- Researchers and scientists: They may use industry guidance to ensure their studies or inventions meet industry standards and requirements.
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- Consumers and the general public: Guidance can help consumers make informed decisions and understand the safety, quality, and proper use of products or services.
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Guidance for industry is a document that provides recommendations and instructions for companies involved in the manufacturing, marketing, and distribution of regulated products.
Companies that are involved in the manufacturing, marketing, and distribution of regulated products are required to file guidance for industry.
To fill out guidance for industry, companies must follow the specific instructions outlined in the document and provide all the required information.
The purpose of guidance for industry is to ensure that companies comply with regulations, meet quality standards, and protect public health and safety.
Information such as product specifications, manufacturing processes, quality control measures, and labeling requirements must be reported on guidance for industry.
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