The Acting Director of the FDA talks about the Center of Excellence, the focus of the epidemic, and the accelerated approval review...

First of all, we need to recover from the epidemic, not drastic reforms

In a speech to the Alliance for a Stronger FDA (Alliance for a Stronger FDA) on April 14, Acting Director of the US FDA, Janet Woodcock said that the current environment is not the right time for the FDA to carry out drastic reforms, and discussed how the FDA will use it.

Center of Excellence

Woodcock said that because the new crown epidemic continues, it has put pressure on FDA staff and increased the workload, so it is not suitable for implementing structural reforms within the agency.

Woodcock said that the FDA is discussing and considering the development of other centers of excellence to take advantage of the "collection across different drug fields," but she also emphasized that now is not the time for institutional reform.

Woodcock admits that the Center of Excellence is a “plus point”, “but we don’t want to do it in a destructive way, and we don’t want exhausted staff to take on more work plans immediately.

Epidemic recovery

Woodcock gave a similar assessment of the FDA's ability to implement the recommendations made in the Pandemic Recovery and Response Plan (PREPP).

The FDA stated that it will first focus on several key areas in the PREPP report:

• Identify ways to improve the EUA review process;
• Identify ways to improve science-based communication with the public;
• Identify methods that can increase the scope of inspection by using next-generation technologies such as virtual and video platforms;
• Identify potential gaps in the medical product supply chain by evaluating the FDA's tracking, monitoring, and evaluation capabilities.
  
  

  Woodcock also said that the funds will also be used to solve supply chain issues, especially advanced manufacturing that may be used to rapidly increase vaccine production.

  
  

  Woodcock also made it clear that the FDA's backlog of inspections of pharmaceutical manufacturing facilities is a top priority.

  
  

  Accelerated approval re-examination

  Accelerated approval re-examination

  When asked whether the recent delays in the approval of some drugs and the re-examination of certain accelerated approval decisions indicate that the FDA is becoming stricter and less willing to adopt flexibility, Woocock said, “I don’t think so.

  
  

  SVB Leerink investment bank analyst Geoffrey Porges recently stated in an investor statement that the FDA may strengthen its position on the industry, especially on safety issues.

  
  

  Other major FDA plans this year include technology and infrastructure modernization projects.

  
  

  Author: Lin know - blue fir