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Feb 11 2019

New FDA Guidances for January 2019

By Zachary Swan, Ph.D., RAC (US), Regulatory Scientist at Cato Research

 FDA draft and final guidances released from CDER, CBER, and CDRH in January are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.

 

Special Interest Guidances/Information Date Posted
Rare Diseases: Common Issues in Drug Development Guidance for Industry Rev. 1 – Draft Guidance 31 Jan 2019
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry – Draft Guidance 30 Jan 2019
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products – Final Guidance 29 Jan 2019
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – Final Guidance 29 Jan 2019
REMS Assessment: Planning and Reporting – Draft Guidance 24 Jan 2019
Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry – Final Guidance 23 Jan 2019
Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway – Final Guidance 22 Jan 2019
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Guidance for Industry – Draft Guidance 16 Jan 2019
Upcoming Meetings (* = New)
February 12, 2019: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* February 12, 2019: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* February 26, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement
* March 6 – 7, 2019: Vaccines and Related Biological Products Advisory Committee Meeting Announcement
* March 8, 2019: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* March 21, 2019: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
* March 27, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement
Last updated: 11 February 2019