FDA Public Workshop: Future Needs for the Development of Interchangeable Products – 09/19/2025

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.

eCTD Submission Standards

Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
 

Unapproved New Drugs/Misbranded

Jubilant HollisterStier General Partnership – 6/14/2024. Country: Canada. Record Type: 483

Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal activity in violation of the U.S. Federal Food, Drug, and Cosmetic Act