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Short of having a spy inside CDER, is there any way to know how and when your applications, schedules and reports will be treated by the FDA?
The answer is yes. That’s because the way CDER does business is all mapped out in its internal policies and procedures…if you know where to look. And now all these crucial policies that drugmakers need to understand are fully updated and organized in The CDER Sourcebook.
Delays, noncompliance and enforcement actions can cripple drugmakers who aren’t aware of the latest in CDER policies. Here’s how to remove those risks.
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 or PDF. In total, it contains more than 1,100 pages and 23 sections, covering topics ranging from document development and management through review and more!
Includes the latest policies and procedures! With this all-new version of the manual, you’ll always be at work with the most current policies. That’s important because there have been major changes since the last edition, including 43 new documents, 34 that have been revised, and 26 that have been withdrawn.
Buy now to align your own policies and practices with CDER’s own decision-making procedures, including:
Don’t risk working with policies that are five years behind how CDER works today! Put the Sourcebook to work now — predicting what CDER will do and protecting your ability to get and keep good drugs on the market.
Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.
Need Extra Print Copies?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Simply choose the quantity you wish to order the discount will be calculated automatically.
3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%
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