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NA LRA Watchdog - October 2023




Darshan Patel, MS
Fred Hutch Cancer Center
United States

Joseph Schwartz, MD, MPH 
Moffitt Cancer Center and Research Institute
United States

Crystal Ruff, PhD, MBA
United Kingdom

FDA CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative:

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) established the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to prepare a regulatory framework to support the adoption of advanced manufacturing technologies that could bring benefits to patients.  Though its Emerging Technology Program, CDER observed the rapid development of advanced manufacturing technologies across drugs it regulates, including innovator and generic or biosimilar products.

FRAME’s Technology Focus:

The National Academies of Sciences, Engineering, and Medicine (NASEM) issued a report identifying innovations CDER is likely to encounter that have the potential to advance pharmaceutical manufacturing.  Based on this report and engagements with stakeholders through the Emerging Technology Program, the FRAME initiative prioritized four technologies:

  • End-to-End Continuous Manufacturing (E2E CM): A fully integrated process into which raw materials are continuously fed, transformed, and finished drug products are continuously removed.
  • Distributed Manufacturing (DM): A decentralized manufacturing platform with manufacturing units that can be deployed to multiple locations.
  • Point-of-Care Manufacturing (POC): A DM platform with manufacturing units in proximity to patient care; for example, at healthcare facilities.
  • Artificial Intelligence (AI): Software and hardware systems that can perceive the environment, interpret data, and decide actions.

During the ISCT North America NA Regional meeting 2023, FDA Chief, Gene Therapy Branch, Dr. Kimberly Schultz, conveyed the FRAME priorities as below. FRAME focuses on four key priorities to develop a regulatory framework for advanced manufacturing technologies:
1.    Seek and Analyze Input to ensure CDER’s understanding of advanced manufacturing technologies is thorough and its analysis of the regulatory framework is science- and risk-based.
    •    CDER plans to solicit stakeholder feedback by releasing discussion papers and holding a public workshop on regulatory areas of consideration for advanced manufacturing technologies.
2.    Address Risks to ensure regulations and policy are compatible with future advanced manufacturing technologies.
    •    Through FRAME, CDER is evaluating our existing risk-based regulatory framework as it applies to these technologies to enable timely adoption of advanced manufacturing technologies.
3.    Clarify Expectations for stakeholders implementing advanced manufacturing.
   •    As a result of FRAME, CDER may issue new or updated guidance to explain the current thinking on a regulatory issue.
4.    Harmonize to ensure global regulatory practice is clear to stakeholders implementing advanced manufacturing.
   •  The FRAME initiative is aligned with FDA’s efforts to work through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop international guidelines related to advanced manufacturing technologies, such as continuous manufacturing, the subject of a new ICH Q13 guideline.

FDA had shared summary overview of the Stakeholder feedback on DM and POC Manufacturing discussion paper published.  This discussion paper presents areas associated with DM and POC manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework as it applies to these technologies.

Under this published paper, FDA shared the received Stakeholders’ feedback.  The stakeholders are seeking agency’s input on regulatory expectations to facilitate implementation of DM and POC technologies for human drug and biologics products, assuring that regulations and policies are compatible with strategies, and International harmonization on the regulations of DM technologies to facilitate adoption for human drug and biologics products. 

CDER’s FRAME Initiative:

Distributed Manufacturing and Point-of-Care Manufacturing of Drugs Discussion Paper:

What’s new for Biologics including Approval and Determination Letters:

COVID-19 Information and Resources:

Guidance Documents:

Upcoming Conferences:


Updates and regulatory news 


Health Canada

What’s new in Biologics, radiopharmaceuticals and genetic therapies can be found at:

Information for health product manufacturers and distributors in relation to COVID-19:


Health-related consultations:


ICH joint consultations:



OTP Town Hall: Nonclinical Assessment of Cell and Gene Therapy Products – August 30, 2023 (Recording is now available)


News Release: FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants – September 11, 2023


Public Virtual Webinar: Warrior Families - Advancing Regenerative Medicine Through Science – October 5, 2023


1-Day Public Workshop: Biomarker-driven Drug Development for Allergic Diseases and Asthma – February 22, 2024


What’s new for Biologics including Approval and Determination Letters:


COVID-19 Information and Resources:


Guidance Documents:


Upcoming Conferences:


Updated Approvals and Listings:

Complete List of Licensed Products and Establishments

Complete List of Substantially Equivalent 510(k) Device Applications

Complete List of Currently Approved Premarket Approvals (PMAs)

Complete List of Currently Approved NDA and ANDA Application Submissions

2023 Biological Approvals

Guidance Documents CBER is Planning to Publish During Calendar Year 2023: