Just released from FDAnews — Investigations Operations Manual 2012 — the FDA’s own internal guidance on how to inspect a drug or device company.

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.

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.

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.

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.

In drug manufacturing, success means staying abreast of regulatory changes from Asia to Argentina ... and beyond. Impossible? Not at all.

What are the five hottest areas of concern showing up in FDA warning letters? How are the agency’s changing priorities impacting its enforcement trends? And what can you do to avoid common pitfalls cited in the FDA’s most recent Warning Letters? The answers are no mystery. They appear in this standout new management report from FDAnews.

The all-new edition of this FDAnews bestseller provides an overview of each of the CDER policies that are important to you, as well as the full-text versions of those 150 policies in a fully searchable CD. In total, it contains more than 1,100 pages and 23 sections, covering topics ranging from document development and management through review and more!

Before you begin to modify an existing trial, this new report from FDAnews maps out the specific planning and preparation it takes to win FDA approval for adaptive clinical trials. By combining a concise overview with a detailed analysis of FDA’s preferences, this one report advises you on everything thing from the best trial model to use to the best way to avoid technical problems with final data analysis.

What would FDA inspectors say if they walked into your lab today and looked at your training records? Are your SOPs up-to-date and complete? Would your sample-handling procedures and archives win praise from an auditor? If you have any doubts, now is the time to take action with this 10-step approach to ensuring quality in GLP-compliant labs…

Are you struggling to cope with negotiating dozens of supplier quality agreements? What topics need to be addressed in every quality agreement? What changes at your suppliers’ operations do you need to know about? Does every supplier even need to have a quality agreement?

No question about it: social media presents a host of problems for drug and device companies. Still, for brands that manage their presence successfully, the upside potential is huge. But what’s the secret to keeping control over your brand as people share on social media? What does an FDA-proof social media presence look like? What happens if consumers use YouTube, Twitter or Facebook to report previously unknown adverse events? How do you present balanced promotions and important safety information using social media? Here’s how to develop a social media strategy that keeps you compliant and competitive.

The Guide to FDA Pharma GMP Regulations – 2011 is a compilation of pharmaceutical GMP regulations that puts all the authoritative information you need in one place.

This new report from FDAnews takes you step by step through how to prepare for and how to conduct yourself during — and after — the critical preapproval inspection.