Unapproved New Drugs
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Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
FDA’s surrogate endpoint table provides valuable information for drug developers on endpoints that may be considered and discussed with FDA for individual development programs.FDA’s ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)
FDA accepts first letter of intent (LOI) into the ISTAND Pilot Program for an organ-on-a-chip technology, a type of micro-physiological system (MPS), to study drug-induced liver injury (DILI) for certain drug candidates.Wells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/25/2025
Short Title (70 char) Wells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
FEI Number 3011761321
Firm Name Wells Pharmacy Inc.
Record Type 483
State TN
Establishment Type Outsourcing FacilityAshfiat Alharamain Energy Support may be harmful due to hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Ashfiat Alharamain Energy Support, a product promoted and sold for male sexual enhancement on various websites, including Amazon.com (Akkarco, LLC storefront), and possibly in some retail stores.Meds for Vets. Sandy, UT. 483 issued 02/21/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/21/2025
Short Title (70 char) Meds for Vets. Sandy, UT. 483 issued 02/21/2025
FEI Number 3003829708
Firm Name Meds for Vets
Record Type 483
State UT
Establishment Type Producer of Sterile & Non-sterile Drug PBroselow Pediatric Emergency Rainbow Tape Recall: AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes due to Misprinted Information
Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.