SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
Effective Date: January 8, 2024
SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications to Pending Applications
Effective Date: October 1, 2022
SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
Effective Date: February 8, 2024
SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications, New Drug Applications and Supplements
Effective Date: October 1, 2022
SOPP 8401.7 – Action Package for Posting
Effective Date: February 27, 2022
SOPP 8402: Designation of Amendments as Major
Effective Date: September 22, 2023
SOPP 8403: Issuance, Reissuance, and Voluntary Revocation of Biological Products Licenses
Effective Date: February 27, 2023
SOPP 8404: Refusal to File Procedures
Effective Date: August 29, 2024
SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
Effective Date: September 7, 2023
SOPP 8405.1: Procedures for Resubmissions to an Application or Supplement
Effective Date: November 13, 2022
SOPP 8406: CBER Processing of PDUFA Application Payments
Effective Date: October 1, 2022
SOPP 8407: Compliance Status Checks
Effective Date: December 11, 2020
SOPP 8408.1: Development of Laboratory Quality Product Testing Plans and Release of Lots as Part of the BLA Approval Process
Effective Date: August 24, 2022
SOPP 8408.3: Lot Release Activities for Licensed Biological Products
Effective Date: September 25, 2019
SOPP 8410: Determining When Pre-License / Pre-Approval Inspections are Necessary
Effective Date: January 6, 2020
SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs)
Effective Date: December 11, 2020
SOPP 8412 – Review of Product Labeling
Effective Date: December 11, 2020
SOPP 8413: Postmarketing Requirement/Commitment Related Submissions – Administrative Handling, Review, and CBER Reporting
Effective Date: February 15, 2024
SOPP 8415: Procedures for Developing Postmarketing Requirements and Commitments
Effective Date: February 15, 2024
SOPP 8416: CBER Intiated Second Level STNs
Effective Date: February 27, 2012
SOPP 8417: Implementation and Management of Risk Evaluation and Mitigation Strategies (REMS)
Effective Date: October 1, 2022
SOPP 8419: Section 505(o)(4) Required Safety Labeling Changes (SLCs)
Effective Date: February 12, 2024
SOPP 8420: FDAAA Section 921 – Posting of Potential Signals of Serious Risk
Effective Date: February 27, 2022
SOPP 8421: Complying with Requirements under the Pediatric Research Equity Act (PREA)
Effective Date: February 27, 2023
SOPP 8422: Processing and Review of Trans-BLA Submissions
Effective Date: February 27, 2023
SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes
Effective Date: July 31, 2024
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"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.
Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.
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