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.
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 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been major changes since the last edition, including 43 new documents, 34 that have been revised, and 26 that have been withdrawn.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.
The CDER Sourcebook is offered by FDAnews in fully searchable CD format, with a book that gives you the introduction and overview for each policy, for $377. Also available as a fully searchable PDF.
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your publication? Return the hard copy and CD within 30 days (in resalable condition), and we will refund 100 percent of your purchase price (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.
Interested in purchasing more than one print copy?
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. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.
Interested in Electronic Multi-user Access?
Phone: +1 (703) 538-7600 or toll free (888) 838-5578