FDA In Brief: FDA provides guidance on improving the agency’s interactions with product developers to make the drug development process more informed and efficient

Apotex Inc. – 05/09/2025. Country: Canada. Record Type: 483

Just as FDA reviews drugs for humans for safety and effectiveness before they can go on the market, the agency does the same for treatments for animals. Learn how FDA brings new oncology treatments to market and questions to ask your vet about your dog’s cancer diagnosis.

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 Facility

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) North American Custom Laboratories LLC dba FarmaKeio Superior Custom Compounding. Richardson, TX. 483 issued 09/05/2025
FEI Number 3014229024
Firm Name North American Custom Labo

Dissemination of pediatric information resulting from pediatric studies done pursuant to FDAAA

Jeni’s Splendid Ice Creams is voluntarily recalling one batch of Passion Fruit Dreamsicle Ice Cream Bars because they may contain undeclared wheat and soy. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reactions if they cons