Scope Health Inc – 695085 – 07/09/2025

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:

FDA hosted its fourth summit on June 8, 2023, as an integral part of FDA’s overall efforts to protect the public, including youth, from harm associated with drugs that have abuse potential.

Record Date 01/27/2016
FEI Number 1000120535
Firm Name New England Home Therapies Inc.
Record Type 483
State MA
Establishment Type Producer of Sterile Drug Products

Costa Mesa, California August 28, 2025 – Green Lumber Holding, LLC (“Green Lumber”) is alerting consumers that counterfeit products misrepresented as genuine Green Lumber have been identified and may pose health risks.

CGMP/Finished Pharmaceuticals/Adulterated

The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products.