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In vitro diagnostic (IVD) device studies, frequently asked questions
2010
Format:
Electronic and Book
✔ Available
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Draft guidance for industry and FDA staff : technical considerations for pen, jet, and related injectors intended for use with drugs and biological products
2009
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Electronic and Book
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Guidance for industry, FDA staff, and FDA-accredited third parties. Manufacturer's notification of the intent to use accredited person under the accredited person inspection program authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).
2009
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Electronic and Book
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Guidance for industry : presenting risk information in prescription drug and medical device promotion
2009
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Guidance for industry : somatic cell therapy for cardiac disease
2009
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User fees and refunds for premarket approval applications
2009
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Electronic and Book
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Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers
2008
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FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals
2008
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Guidance for industry and FDA staff : expedited review of premarket submissions for devices
2008
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Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
2008
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