As the gyrating soup of chemotactic antigenic immunocircus converges on the insignificant hand wound I incurred in the field today at work,
my mind is distracted and wends it's way wistfully t'ward page 34 of
SOPP 8401: Administrative Processing of Original Biologics License
Applications (BLA) and New Drug Applications (NDA)
Version: 18
Effective Date: January 8, 2024wherein I reflect on the procedural excitement no doubt enjoyed by a select few at CBER
in whose hands critical science filters through to the madding crowd cupped broiling and roiling
in the unseeing hands of inexorable natural selection and it's forces we seek to tame and direct
as we strive to science the hell out of this mortal coil.
esp. to wit, Step 154.
Truely, we need to open a book on the BLA response date - for mine, $5 on 10/10/2024.
LINK (pdf download)
149. Perform a quality control review of the CBER generated documents related to the
application, ensuring that all documents are in the CER, dates are correct, and
documents are properly signed; the electronic Action Package (eAP) can be used as a
resource. [RPM]
150. Send the final draft Approval Letter to all appropriate Review Offices, Branch Chiefs, and
Division Directors for review and agreement. [RPM, Chair]
151. Review and comment or concur on Approval Letter. [appropriate review offices,
Branch Chiefs, and Division Directors]
152. Send the Approval letter, SBRA and transmittal memo (T 910.01: Transmittal Memo) for
signature. [RPM] Note: a link to the eAP may be included for Office Director’s reference
and review during the sign-off process.
153. Sign the Transmittal Memo, SBRA and Approval Letter. [Office Director(s)]
a. Signatory Authority for SBRA and Approval Letter
i. Original BLAs (for existing U.S. License Number)/NDAs:
a) Office Director or Deputy Office Director, product office
ii. Original BLAs (for new U.S. License Number)
a) Office Director or Deputy Office Director, product office AND
b) Office Director or Deputy Office Director, OCBQ
154. Issue the Approval Letter and communicate the approval to the applicant. [Chair, RPM]
(20min delay)