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:
Forty-seven percent of CRLs name deficiencies in CMC requirements. Imagine knowing which areas the FDA faults, then resolving these problems in advance.
The same percentage of CRLs list deficiencies related to product labeling. Here, too, knowledge is power — to resolve deficiencies before a CRL arrives.
Forty-five percent of CRLs include comments related to specific clinical deficiencies, many of which could be addressed during the drug development process to avoid unnecessary delays in an application’s review.
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:
The most common reasons CRLs are issued and how to prevent them?
Key turning points in working with the FDA that sponsors must not ignore?
Impact of various types of CRLs on time-to-market?
Strategies for clearing FDA CRL objections without needless delays?
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.
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Theresa Allio Ph.D. has 10 years’ experience in drug development, including service in academia, industry and the FDA. She started her career at Vertex Pharmaceuticals, serving a key regulatory role on the Incivek and Kalydeco development teams. While at the FDA, she served as a nonclinical reviewer and as support staff for the Pediatric Advisory Committee.
Here’s a suggested list of potential readers:
Regulatory affairs staff
Drug company executives
Clinical trial operators
Board of Directors members
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