Division of Applied Regulatory Science

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/23/2025
Short Title (70 char) Tailstorm Health Inc dba Medivant Healthcare
FEI Number 3015929581
Firm Name Tailstorm Health Inc
Record Type 483
State AZ
Establishment Type Outsourcing Facility

This guidance is the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for product development decision-making.

The FDA aspires to assist applicants in developing abbreviated new drug applications (ANDAs). To facilitate the development of an ANDA, agency provides the following resources on ANDA forms and submission requirements.

On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other ar

Plainview, NY. October 27, 2025— Purity Products is announcing a recall of one lot of of its dietary supplement MyBladder because it has the potential to be contaminated with Escherichia coli O7:K1 and 1303. The presence of these E. coli strains may pose a risk for gastrointestinal or other infectio

Medline is recalling certain Convenience Kits due to being labeled as sterile but not having gone through the sterilization process