Special Protocol Assessment - ✔✔FDA will respond within 45 days
whether acceptable or not.
Types of protocols related to PDUFA products are eligible for special protocol
assessment - ✔✔(1) animal carcinogenicity protocols, (2) final product stability
protocols, and (3) clinical protocols for phase 3 trials whose data will form the
primary basis for an efficacy claim if the trials had been the subject of
discussion at an end-of-phase 2/pre-phase 3 meeting with the review division,
or in some cases, if the division agrees to such a review because the division is
aware of the developmental context 2 in which the protocol is being reviewed
and the questions are being answered.
,Special Protocol Assessment should be - - ✔✔-Application should be submitted
to the agency 90 days before the start of the clinical trial.
-Special protocol assessment will not be provided after a study has begun.
-A sponsor should submit each protocol for assessment under this program as a
separate amendment to the sponsor's IND in triplicate with Form FDA 1571 and a
cover letter attached.
-The decision of the review team should be sent to the sponsor in a special
protocol assessment letter within 45 calendar days of receipt of the request .
-If a sponsor requests a meeting with CDER or CBER after receipt of a special
protocol assessment letter, the request will be handled as a request for a Type A
meeting.
21 CFR 314.53(d)(2) - ✔✔An applicant is required to submit patent information
when approval is sought in supplements involving a formulation change, a new
condition of use, a new indication, a change in the route of administration, a
, change in strength or any other patented change regarding the drug, drug
product or method of use.
How should an NDA holder report a change to filtration parameters for aseptic
processing (including flow rate, pressure, time or volume, but not filter material
or pore size rating). - ✔✔Changes Being Effected in 30-Days (moderate potential
to have an adverse effect on the identity, strength, quality, purity, or potency of a
drug product as these factors may relate to the safety or effectiveness of the
drug product).
Changes to filtration parameters for aseptic processing (including flow rate,
pressure, time, or volume, but not filter materials or pore size rating) when
additional validation studies for the new parameters should be performed.
An NDA holder wants to extend the drug product shelf life from two to three
years. What is the best course of action to pursue? - ✔✔Present three years
of real-time stability data on three consecutive batches following an approved
stability protocol in the NDA Annual Report
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