FDA Posted Guidance Documents

New FDA Posted Guidance Documents

• 1/6/2021 – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff
• 1/6/2021 – Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
• 1/5/2021 – Mouse Embryo Assay for Assisted Reproduction Technology Devices
• 1/5/2021 – Human Gene Therapy for Neurodegenerative Diseases: Draft Guidance for Industry
• 1/4/2021 – IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators

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Categories Policies & Guidance
Tagged FDA Guidance, medical devices, Q-sub