FYI, I was just stating a fact and answering anoth
Post# of 154816
(Total Views: 568)
Posted On: 06/01/2020 4:36:47 PM
Re: ClosetInvestor #36150
FYI, I was just stating a fact and answering another poster, not "discussing". And yes, I think they could have completed it at the same time, since this how the FDA requires it anyway and since it requires just a "concise summary" why the sponsor thinks the product offers significant advantages. Turns out that the FDA does not want to receive requests AFTER the submission, and since NP prides himself with playing the FDA play-book 100% correctly, well, Fortuno's question was legitimate (see the guidelines below)... So, I will just answer that question despite that little rebuke 
FDA determines whether an application qualifies for priority review (versus standard review) for
every application, not just when priority review is requested by the applicant.
However, an
applicant may expressly request priority review as described in the following sections.
1. When to Send a Designation Submission
Sponsors may request priority review designation when they submit an original BLA, NDA, or
efficacy supplement. The Agency does not anticipate that priority review designation requests
will be made after the filing of a BLA, NDA, or efficacy supplement. (!!!!!)
2. Where to Send a Designation Submission
Priority review designation requests may be submitted with the original BLA, NDA, or efficacy
supplement to the attention of the appropriate review division or office in CDER or CBER.
3. Content of a Designation Submission
Priority review designation requests should contain the following information:
Identification of the submission in the cover letter as a REQUEST FOR PRIORITY
REVIEW DESIGNATION in bold, uppercase letters.
In the cover letter of the submission, the name of the sponsor’s contact person and the
contact person’s address, email address, telephone number, and fax number.
If available, for drug products, the proprietary name and active ingredient and for
biological products, the proper name and proprietary name.
The proposed indication(s).
A concise summary of information that supports the priority review designation request,
including the following:
o The basis for considering the drug to be intended to treat a serious condition
o The basis for the assertion that the drug would be a significant improvement in the
safety or effectiveness of the treatment, prevention, or diagnosis of a serious
condition
FDA determines whether an application qualifies for priority review (versus standard review) for
every application, not just when priority review is requested by the applicant.
However, an
applicant may expressly request priority review as described in the following sections.
1. When to Send a Designation Submission
Sponsors may request priority review designation when they submit an original BLA, NDA, or
efficacy supplement. The Agency does not anticipate that priority review designation requests
will be made after the filing of a BLA, NDA, or efficacy supplement. (!!!!!)
2. Where to Send a Designation Submission
Priority review designation requests may be submitted with the original BLA, NDA, or efficacy
supplement to the attention of the appropriate review division or office in CDER or CBER.
3. Content of a Designation Submission
Priority review designation requests should contain the following information:
Identification of the submission in the cover letter as a REQUEST FOR PRIORITY
REVIEW DESIGNATION in bold, uppercase letters.
In the cover letter of the submission, the name of the sponsor’s contact person and the
contact person’s address, email address, telephone number, and fax number.
If available, for drug products, the proprietary name and active ingredient and for
biological products, the proper name and proprietary name.
The proposed indication(s).
A concise summary of information that supports the priority review designation request,
including the following:
o The basis for considering the drug to be intended to treat a serious condition
o The basis for the assertion that the drug would be a significant improvement in the
safety or effectiveness of the treatment, prevention, or diagnosis of a serious
condition
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