Food Blog
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Friday, December 10, 2021
Recently Posted Guidance Documents
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Recently Posted Guidance Documents
12/9/2021 -
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
12/9/2021 -
Development of Anti-Infective Drug Products for the Pediatric Population : Guidance for Industry
12/9/2021 -
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment : Draft Guidance for Industry
12/8/2021 -
Tobacco Product User Fees: Responses to Frequently Asked Questions
12/8/2021 -
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry
12/7/2021 -
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators : Draft Guidance for Industry
12/7/2021 -
Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations: Draft Guidance for Industry
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