Be the first to receive the new 2008 official FDA Code of Federal Regulations (CFR) for drug and biologic manufacturers! The federal government has compiled the new Title 21 CFR with all the FDA rules for drugs and biologics revised through April 1, 2008.  Update your library with the latest additions and revisions to the CFR governing good manufacturing practices (GMPs), Part 11 electronic records and signatures, drug enforcement policies, protection of human subjects, good laboratory practices, new drug approval, biologics product licensing and more.

The federal government has just compiled the new Title 21 CFR Nine-volume Set for 2008 with all of the FDA rules for drugs, devices and biologics revised through April 1, 2008. Update your library with the latest additions and revisions to the CFR governing food and drugs used in humans and animals, biologics, cosmetics, medical devices, radiological health and controlled substances.

Be the first to receive the new 2008 official FDA Code of Federal Regulations (CFR) for device and diagnostics manufacturers. The federal government has compiled the new Title 21 CFR with all the FDA rules revised through April 1, 2008. Reserve your two-volume 2008 Title 21 CFR Devices/Diagnostics set now for priority shipping immediately as each volume is released over the coming months.

From FDAnews — Adverse Event Compliance in Device and Diagnostics Clinical Trials. Find clear, concise guidelines on adverse event reporting — specifically for device and diagnostics trials. Make sense of all the whats, whens and hows surrounding adverse event reporting. Once an adverse event happens, it’s too late: you have just 10 working days to submit to the IRB and 10 days after that to get results to the FDA. Stay in control, even when unanticipated events happen.

Adverse Event Compliance in Drug and Biologic Clinical Trials, the management report from FDAnews gives dependable guidance on adverse event reporting specifically for drug and biologic companies. Make sense of the key rules and requirements of the FDA and the OHRP and find out what the FDA considers a reportable effect.

Get the essential information you need to make smart, strategic decisions about the high-growth, global pharmaceutical sector with this report published by Espicom.

For the first time, here's an impartial look at where authorized generics stand in Congress, court, authorized generics and the market — and how competitive responses from brand and generic firms will determine who ultimately stands in the winner's circle.

This management report from FDAnews zeroes in on change control to give you a real-world understanding of today's best practices as well as what's ahead. It examines change control from a unique manufacturing and QA perspective, you'll learn what drives the FDA's quality systems guidance and what's shaping today's inspection trends.

This strategic report includes the information you need to assess and thrive in the generic biotechnology market.
Published by Espicom, Inc.

Order today, and you'll firmly grasp current biosimilar issues, easily explain key points to your colleagues and superiors, make well-informed decisions regarding your own products and better position products for the coming conflicts and evolving regulations.

Get the essential information you need to make smart, strategic decisions about this tantalizing, high-risk/high-reward global pharmaceutical sector. This report provides a strategic analysis of the size, nature and future direction of the world market for biogeneric drugs, and thoroughly explores the sector's most critical concerns.

Published by Espicom — Blood Cancer Drug Discoveries: What the Future Holds, the new strategic report provides a comprehensive review of current and future treatments for such major blood cancer therapy areas as chronic lymphocytic leukemia, chronic myeloid leukemia, acute myeloid leukemia, and multiple myeloma and non-Hodgkin's lymphoma.

British Pharmacopoeia (BP) 2008 is the authoritative, current collection of standards for UK medicinal substances and the official source of all UK quality standards. This essential reference plays a vital role in ensuring that all medicinal substances sold in the UK market continue to meet stringent standards of safety, quality and efficacy.

This 652-page market analysis report provides a unique examination of four key therapy areas: breast, colorectal, prostate and non-small cell lung cancer. Evaluate your potential for profit in the $24 billion dollar oncology market.
Published by Espicom, Inc.