Recently Posted Guidance Documents on Aquaculture, Minor Use/ Minor Species (MUMS);Digital Health, Premarket, Postmarket; Clinical - Medical; Electronic Submissions; Pharm/Tox

Aquaculture, Minor Use/ Minor Species (MUMS) 

4/27/2018 CVM GFI #210 The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

Digital Health, Premarket, Postmarket

4/27/2018  Multiple Function Device Products: Policy and Considerations - Draft Guidance for Industry and Food and Drug Administration

Clinical - Medical

4/26/2018 Clinical Trial Imaging Endpoint Process Standards Guidance for Industry

Electronic Submissions

4/24/2018 Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

Pharm/Tox

4/23/2018  Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals Guidance for Industry