FDA Complete Response Letter Analysis
How 51 Companies Turned Failure to Success
A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.
Imagine how much you could save if you could anticipate the FDA’s concerns and address them before the agency issues the complete response letter? Now you can.
Researcher Theresa Allio, Ph.D., analyzed CRLs issued for 51 products approved by the FDA since 2009 and discovered striking underlying patterns:
And this is just the tip of the iceberg. To discover the patterns CRLs share, Dr. Allio analyzed dozens of these documents. Her work makes crystal clear exactly which deficiencies could trigger CRLs in your company — and how to head them off.
Reading FDA Complete Response Letter Analysis can be an eye-opening experience. Do you know:
Understanding what triggers a CRL, and what to do if you get one, can save millions of dollars and months of delay — years, even — getting products to market. Here’s how to gain that understanding — in about one hour of reading time.
Table of Contents
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 FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.
Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.