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Feb 04 2020

New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS

Special Interest Guidances/Information Date Posted
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020
Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 28 Jan 2020
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Retinal Disorders: Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Rare Diseases: Guidance for Industry – Final Guidance 28 Jan 2020
Human Gene Therapy for Hemophilia: Guidance for Industry – Final Guidance 28 Jan 2020
Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry – Final Guidance 28 Jan 2020
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up: Guidance for Industry – Final Guidance 28 Jan 2020
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry – Draft Guidance 27 Jan 2020
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry – Final Guidance 24 Jan 2020
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry – Final Guidance 23 Jan 2020
Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry – Final Guidance 23 Jan 2020
In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry – Final Guidance 23 Jan 2020
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff – Final Guidance 22 Jan 2020
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry – Draft Guidance 22 Jan 2020
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers: Draft Guidance for Industry – Draft Guidance 15 Jan 2020
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff – Draft Guidance 13 Jan 2020
Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization: Guidance for Industry – Final Guidance 02 Jan 2020
Upcoming Meetings (* = New)
* February 26, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting
* March 4, 2020: Vaccines and Related Biological Products Advisory Committee Meeting

Last updated: 04 February 2020