Risk Evaluation and Mitigation Strategies | REMS

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA)…

Upcoming Product-Specific Guidances for Generic Drug Product Development

This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval…

FedEx names CEO for Freight post-spinoff

John A. Smith, who led the LTL carrier from 2018 to 2021, will take the helm once the move is…

Stanley Black & Decker raises prices to mitigate tariff impacts

The company is also making supply chain moves to become more compliant with the U.S.-Mexico-Canada agreement and reduce its manufacturing…

Supreme Service Solutions LLC Voluntarily Recalls Supreme Vegetable Products Because of Possible Health Risk

Supreme Service Solutions LLC. (dba Supreme Produce) is assisting in a Kroger Store recall for items purchased from Bedner Growers…

Combination Products Performance Reports

Annual report to Congress on the activities and impact of the Office of Combination Products (OCP)

Canada Post union issues Friday strike notices

The carrier expects either a nationwide labor disruption or rotating strike activity once current agreements expire.

China tariff reduction drives uptick in Asia-to-US bookings

Shippers are pushing to import goods before the 90-day reprieve expires, Port of Los Angeles leader Gene Seroka said.

FishMoxFishFlex/Simple Pet Health LLC – 707196 – 05/08/2025

Unapproved New Animal Drug/Misbranded

NWL Netherlands Services B.V. – 701206 – 04/01/2025

CGMP/Finished Pharmaceuticals/Adulterated