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.

Order Today

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been major changes since the last edition, including 43 new documents, 34 that have been revised, and 26 that have been withdrawn.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:

• How the FDA addresses key topics, such as dispute resolution; submitting issues and documents to the Office of the Chief Counsel; consulting the controlled substance staff; procedures for review of bioequivalence study protocols; CDER’s handling of adverse experience reports, and more.

• All-new information on the Office of Medical Policy; Office of Executive Programs, Office of Drug Evaluation, Office of Translational Sciences, Administrative Management, and medical/statistical documents that did not appear in the previous 2007 edition.

• How CDER operates: How it determines when and how informed consent documents submitted under an investigational new drug application will be reviewed.

• Good review practices: How CDER approves and selects the good review practices it uses in reviewing clinical safety and marketing application reviews.

• Application evaluations: How CDER evaluates new drug applications and biologics license applications to determine whether they are priority or standard; and how it sets timelines, milestones and the goal date by which an application is reviewed under PDUFA.

• Information review and communication: e.g., how CDER reviews new drug master files and establishes procedures for informing applicants of the planned review timeline and goal dates for discussion of labeling and postmarketing study requirements.

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.

Buy Now!
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.

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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.