QIDP definition
Examples of QIDP in a sentence
Accordingly, the Agency will analyze any collection of information or additional PRA-related burdens associated with the QIDP designation process separately.
That is, a drug intended to treat a serious or life- threatening bacterial or fungal infection caused by a pathogen that is not included on the list of ‘‘qualifying pathogens’’ may be eligible for designation as a QIDP, while a drug that is intended to treat an infection caused by a pathogen on the list may not always be eligible for QIDP designation.
Inclusion of a pathogen on the list of ‘‘qualifying pathogens’’ does not confer any information collection requirement upon any party, particularly because inclusion of a pathogen on the list of ‘‘qualifying pathogens’’ and the QIDP designation process are distinct processes with differing standards.
QIDP designation, by definition, requires that the drug in question be an ‘‘antibacterial or antifungal drug for human use intended to treat serious or life- threatening infections’’ (section 505E(g) of the FD&C Act).
In November 2014, Talicia® was granted Qualified Infectious Disease Product (QIDP) designation by the FDA.
With the QIDP designation, intended for antibacterial or antifungal drugs that treat serious or life-threatening infections, together with new chemical entity (NCE) designation, Aemcolo® enjoys marketing exclusivity until 2028.
Thus, the comment asserted, Congress intended the qualifying pathogen list to provide ‘‘some certainty and transparency’’ regarding which products may be eligible for QIDP designation.
The QIDP designation process will be addressed separately by the Agency at a later date.
To alleviate confusion regarding this issue, FDA also clarifies that vaccine applications are ineligible for QIDP designation under the GAIN title of FDASIA.
Thus, under the law, vaccines are ineligible for QIDP designation.