What factors does the FDA consider when it decides to conduct a preapproval inspection of a drugmaker, and what can you do to minimize the chances of being selected?
What special areas of emphasis will FDA focus on during a preapproval inspection?
How do you — and your partners — need to prepare for these inspections?
Any company submitting a new drug application or major supplement to an existing application can be chosen for a preapproval inspection. These inspections can trip up even experienced drugmakers, and the consequences are painful: delays in manufacturing, liability issues, splashover effects on other products, and damage to a firm’s reputation.
Now’s the time to prepare for a preapproval inspection.
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.
By taking the mystery out of what to expect, the report gives you far more power to make sure everything is in order, from records to cGMPs. Plus, you’ll learn how to reduce your chances of even having a preapproval inspection.
Buy now to get to market as fast as possible by answering the right questions, including:
Remember: the preapproval inspection isn’t just an ordinary inspection. It’s the FDA’s first chance to determine the manufacturing quality for your drug product.
A smooth inspection not only helps you get to market sooner, it helps set the tone for future inspections of this and other products your company manufactures. Let this report help you prepare effectively.
Offered by FDAnews in print or PDF format for $377 each.
There's no risk when you purchase from FDAnews with our money-back guarantee. Not satisfied with your publication? Return the hard copy 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