Are you ready to file an NDA or BLA? Are you really ready? Once your application is submitted, the scrutiny begins — from your preclinical data to your standard operating procedures to literally any other aspect of your business the Agency feels appropriate.
While the process of completing and submitting a Form 356h is straightforward, the Agency's parameters and expectations are changing all the time. There's good reason that the average first-review approval rate sits just north of 61 percent across a sampling of 15 disease areas. Preparation is paramount.
To help ensure you're really prepared, we've assembled a collection of recent articles on the topic into this e-book. In it, you'll find timely and authoritative advice from some of the field's foremost experts, including Michael Cooper, who leads Clinical and Regulatory Affairs at Pharmatech Associates, Mark Durivage of Quality Systems Compliance LLC, and S. D. Devendra Raj, Ph.D., Sr. Manager of Regulatory Publishing Services at Freyr.