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What’s New for Biologics

by | Aug 30, 2024 | News From Around The Web | 0 comments

8/30/2024 August 29, 2024 Approval Letter – ACAM2000 8/30/2024 CBER Title 21 Vacancy Announcement – Branch Chief, AD-0343-Band D, Office of Management (OM)
Closes: September 20, 2024 8/29/2024 August 29, 2024 Approval Letter – ELEVIDYS 8/29/2024 Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff 8/29/2024 August 28, 2024 Approval Letter – COMIRNATY 8/27/2024 BK241081 – Blood Product Administration Module (BPAM 4-2023) 8/26/2024 August 23, 2024 Approval Letter – MACI 8/26/2024 CBER Title 21 Vacancy Announcement – Program Analyst, AD-0343-Bands A/B – Planning, Performance, and Formulation Branch (PPFB), Division of Management Planning and Analysis (DMPA), Office of Management (OM)
Closes: September 3, 2024 8/23/2024 Electronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff 8/23/2024 FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff 8/23/2024 Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff 8/22/2024 August 22, 2024 Approval Letter – SPIKEVAX 8/22/2024 August 21, 2024 Approval Letter – AREXVY 8/21/2024 BK241080 – ImmuLINK (v3.2) 8/20/2024 August 19, 2024 Approval Letter – BEXSERO 8/20/2024 Vaccines and Related Biological Products Advisory Committee Meeting Announcement
September 20, 2024 8/19/2024 August 13, 2024 Approval Order – INTERCEPT Blood System for Plasma 8/19/2024 August 1, 2024 Summary Basis for Regulatory Action – TECELRA 8/19/2024 CBER Title 21 Vacancy Announcement – Physician, Band C, Office of Therapeutic Products (OTP), Office of Clinical Evaluation (OCE)
Closes: November 30, 2024 8/14/2024 Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry 8/14/2024 Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment; Draft Guidance for Industry 8/14/2024 July 31, 2024 Clinical Review Memo-FIBRYGA 8/14/2024 July 31, 2024 Statistical Review Memo-FIBRYGA 8/14/2024 August 5, 2024 Approval Letter – ADSTILADRIN 8/13/2024 Staff Fellow – Researcher-Reviewer
Closes: November 30, 2024 8/12/2024 Title 21 Vacancy Announcement – Consumer Safety Officer, AD-0696-A/B, Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing and Product Quality (DMPQ)
Closes: August 30, 2024 8/9/2024 2024 Center for Biologics Evaluation and Research (CBER) Science Symposium 8/8/2024 BK231025 – Aptima HIV-1 Quant Dx Assay 8/7/2024 Demographic Data Summaries for CBER Novel Biological Approvals by Year 8/7/2024 User Fee Billable Biologic Products and Potencies Approved Under Section 351 of PHS Act
Update 8/7/2024 August 6, 2024 Approval Letter – FluMist 8/7/2024 CBER-Regulated Products: Resolved Shortages
Rho(D) Immune Globulin (Human) 8/6/2024 CBER 2024 Orphan Approvals (new BLAs) 8/6/2024 Vaccines for Children – A Guide for Parents and Caregivers 8/6/2024 Joint FDA Workshop: Developing vaccines for fungal diseases: Coccidioidomycosis/Valley fever – August 13 &14, 2024
Draft Agenda available. 8/6/2024 FDA CBER OTP Town Hall: CMC Readiness for Gene Therapy BLAs, June 4, 2024
Town Hall transcript available. 8/5/2024 BK241074 – SeCore CDx HLA Sequencing System 8/2/2024 CBER Vacancy: Staff Fellow – Product/Chemistry, Manufacturing and Controls (CMC) Reviewer
Closes: October 31, 2024 8/2/2024 CBER Vacancy: Staff Fellow/Visiting Associate – Parasitic Diseases
Closes: September 1, 2024 8/2/2024 August 1, 2024 Approval Letter – TECELRA 8/2/2024 CBER-Regulated Products: Resolved Shortages
Coagulation Factor VIIa (Recombinant) 8/2/2024 OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
Question submission date extended through Tuesday, August 6th. 8/2/2024 Complete List of Licensed Products and Establishments
Update 8/2/2024 Complete List of Substantially Equivalent 510(k) Device Applications
Update 8/2/2024 Complete List of Currently Approved Premarket Approvals (PMAs)
Update 8/2/2024 Complete List of Currently Approved NDA and ANDA Application Submissions
Update 8/1/2024 Statistical Review – PALFORZIA 8/1/2024 July 23, 2024 Clinical Review Memo – PALFORZIA 8/1/2024 July 31, 2024 Approval Letter – FIBRYNA 8/1/2024 SOPP 8426: Assignment of Biological and Drug Product Proper Names and Biological Suffixes

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Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"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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