Books & CDs

The REMS Compliance Guide

New book that guides you to deal with FDA's Risk Evaluation and Mitigation Strategies. Includes FREE Copy of our Drug & Device Answerbook and a handy CD-ROM of FDA and EU pharmacovigilance nad REMS guidance. $284 -- but is FREE if you subscribe to Adverse Event Reporting News (unlimited PDF edition)

Pharmaceutical Supply Chain Compliance Manual

This handy manual contains all FDA, EU and WHO guidance on securing the drug supply chain, including track-and-trace and how to thwart counterfeiting. $349, but free with an unlimited subscription to Food & Drug Inspection Monitor (Special offer!)

FDA Computer, Software & Cybersecurity Manual

Keep your computers, software and mobile devices -- and data secure. This new manual compiles FDA, EU and other important guidance documents and guidelines on cybersecurity, computers and software in devices as well as in use in pharma/biotech manufacturing. FREE if you subscribe to Validation Times, our GMP validation newsletter, or click here to order the manual ONLY at $619

483s/EIRs on CD

14 years of 483s, EIRs for drugs, devices, biologics, BiMo. $799 for a complete set. For product-specific CD pricing, click here:

510(k)s/PMAs on DVD

Hundreds of 510(k)s, PMA summaries dating back to late 1980s. $883

Warning Letters on DVD

Get 10 years of FDA warning and "untitled" letters on DVD. Searchable, too. Just $795. Regularly, $2,995