FDA is issuing new guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). FDA is concerned that large volume of saleable returns coupled with

The pharmaceutical industry has reason to celebrate. After a 2-year delay, the U.S. Food and Drug Administration (FDA) has published a grandfathering policy, which specifically

Today FDA issued draft DSCSA compliance guidance on how to identify DSCSA Trading Partners. This draft guidance provides clarity on how to classify trading partner

One Year Enforcement Delay – Not!? Hidden Timetable in DSCSA Product Identifier Requirements With about 100 working days left until the November 27, 2017 deadline

As of January 1, 2015 the DSCSA mandated that all healthcare practitioners who dispense or administer prescription drugs to patients must purchase their prescription drug

Doctors, nurses, purchasing agents, pharmacists, office managers and other health care professionals are being warned by the FDA to Know Your Source. The FDA is

Using serialized information to Gain Compliance and Add Business Value All pharmaceutical manufacturers with prescription drugs destined for the United States market must address the

Trading Partners Get Early New Year’s Gift As a result of industry pressure, the FDA has delayed enforcement of Drug Supply Chain Security Act (DSCSA)

HDMA urges FDA to Exercise Enforcement Discretion The Healthcare Distribution Management Association (HDMA) recently wrote the FDA and expressed their concern about the pharmaceutical supply

The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include Unique Device Identifiers, or UDIs, on medical devices. Each