#6: Expedited Programs for Serious Conditions – Drugs and Biologics

December 8, 2016

In May 2014, the FDA published a guidance document entitled “Expedited Programs for Serious Conditions – Drugs and Biologics.”  The intention of the document was to provide drug makers with an incentive to develop products that fill unmet medical needs for serious conditions.  Since its publication, the program established by the guidance document has become an increasingly popular pathway for many companies developing new drug products.

To learn more about this guidance document and its contents, view our previous blog post on the topic, entitled “Taking the Mystery Out Of Expedited Approvals.”

Do you think your product may fall into the category of drugs covered by this incentive program?  Are you seeking expedited approval for an applicable drug product?  We can help you achieve a successful interaction with FDA.  To learn more about our services and capabilities, contact us today.

If you have any questions or thoughts on this blog post or others, please contact us today.


April 18, 2022

FDA releases Guidance for Industry on Bioavailability Studies Submitted in NDAs or INDs — General Considerations

FDA issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs),...

June 14, 2016

FDA Clarifies Regulations Regarding How Patients May Be Charged for Investigational Drugs

On Thursday, June 2nd the FDA issued a final guidance, entitled “Charging for Investigational Drugs Under an IND — Questions and Answers.” The guidance provides information concerning the...

June 8, 2022

Compounded drug search added to FDA’s NDC directory webpage

FDA recently added a search function to the National Drug Code (NDC) Directory webpage for human drugs compounded by outsourcing facilities that assign NDC numbers to their products. This update was...