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FDA Pharmaceutical and Medical Device Books

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Clinical Trials Adverse Event Reporting Reference Guide, Second Edition

Published: June 2012 |  Price:  $377
Something’s gone wrong in one of your clinical trials. But ... is it an adverse event? What should you do next? Get the facts.

FDA Device Enforcement: An Analysis of Warning Letter Trends

Published: May 2012 |  Pages: 67 |  Price:  $377  | ISBN:  978-1-60428-033-3
This thorough overview of FDA medical device enforcement trends reveals what triggered 2011 warning letters, and where investigators will be training their sites in the months ahead.

Medical Device Manufacturer CAPA Benchmarking Survey

Published: May 2012 |  Price:  $457
Wondering what would improve your device company’s CAPA performance? We have answers from an exclusive, new FDAnews survey of devicemakers.

Investigations Operations Manual 2012

Published: May 2012 |  Price:  $377
Just released from FDAnews — Investigations Operations Manual 2012 — the FDA’s own internal guidance on how to inspect a drug or device company.

Two-Volume Devices/Diagnostics Title 21 CFR Set

Published: April 2012 |  Price:  $160
Order your Two-Volume Devices/Diagnostics Title 21 CFR Set today! The federal government has just compiled the new devices/diagnostics-related Title 21 CFR volumes for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

Five-Volume Drugs/Biologics Title 21 CFR Set

Published: April 2012 |  Price:  $300

Order your Five-Volume Drugs/Biologics Title 21 CFR Set today! The federal government has just compiled the new drugs/biologics related Title 21 CFR volumes for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.


Nine-Volume Title 21 CFR Set

Published: April 2012 |  Price:  $585
Order your Nine-Volume Title 21 CFR Set today! The federal government has just compiled the new Nine-Volume Title 21 CFR Set for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

Two-Volume Clinical Trial Title 21 CFR Set for Drugs

Published: April 2012 |  Price:  $125
Order your Two-Volume Clinical Trials Title 21 CFR Set for Drugs today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for drugs for 2012 with all of the FDA rules for drugs and biologics updated through April 1, 2012.

Two-Volume Clinical Trial Title 21 CFR Set for Devices

Published: April 2012 |  Price:  $160
Order your Two-Volume Clinical Trials Title 21 CFR Set for Devices today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for devices for 2012 with all of the FDA rules for devices updated through April 1, 2012.

Three-Volume Clinical Trials Title 21 CFR Set

Published: April 2012 |  Price:  $210
Order your Three-Volume Clinical Trials Title 21 CFR Sets today! The federal government has just compiled the new clinical trial-related Title 21 CFR volumes for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

Title 21 CFRs

Published: April 2012 |  Price:  $50
Order your individual Title 21 CFRs today! The federal government has just compiled the new Title 21 CFRs for 2012 with all of the FDA rules for drugs, devices and biologics updated through April 1, 2012.

China’s Guidebook for Application and Approval of Imported Medical Device Registration

Published: April 2012 |  Pages: 155 |  Price:  $750
In this clear yet comprehensive new resource developed by Access China Management Consulting Ltd., FDAnews provides an English-language guide that makes it easier to navigate the Chinese medical device registration system.

China’s Guidebook for Pharmaceutical Patent Protection

Published: April 2012 |  Pages: 231 |  Price:  $1,495
With a new resource developed by Access China Management Consulting Ltd., FDAnews offers non-Chinese companies the know-how to move into China’s lucrative pharmaceuticals market without giving up their intellectual property rights.

FDAnews Guide to International Pharma Regulation: 2012 Edition

Published: April 2012 |  Pages: 391 |  Price:  $387  | ISBN:  978-1-60428-027-2
In drug manufacturing, success means staying abreast of regulatory changes from Asia to Argentina ... and beyond. Impossible? Not at all.

FDAnews Guide to International Medical Device Regulation: 2012 Edition

Published: April 2012 |  Pages: 416 |  Price:  $387  | ISBN:  978-1-60428-025-8
In medical device manufacturing, success means staying abreast of regulatory changes from Asia to Argentina ... and beyond. Impossible? Not at all.

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