Regulatory Guidance

In these challenging times, global health authorities and governments are continously issuing guidance that could impact the conduct of your clinical development programs.  Whether you are trying to fast-track a COVID vaccine or therapy, or you have a valuable therapy in development - having the right guidance and agency relationship is pivotal to your success.  Don’t worry about the unknown, let the agile and scientific-minded Veristat experts assist you in reaching your next milestone, and the one after that.

 

COVID-19 Therapy Acceleration

For sponsors of investigational products that may be relevant to diagnosing, preventing, treating, or managing the symptoms of COVID-19, FDA has created a new Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as quickly as possible.

Members of the Veristat regulatory team have already interacted with this group and can share a few preliminary takeaways:

  • The CTAP team at FDA is extremely responsive. Requests for feedback on clinical study designs and other development questions have received responses in as little as 3 days.
  • Sponsors seeking to access this program should be “ready to go.” Sponsors seeking feedback on early development questions or encountering manufacturing challenges should expect to file a traditional pre-IND meeting request.
  • For products with existing INDs for other indications, FDA has been requesting submission of new INDs for COVID-19-related indications, rather than allowing an amendment to the existing IND to add the new COVID-19 indication.
  • Looking for some guidance? Take a look at our COVID-19 Success Guide: Success Strategies for Conducting Clinical Trials During the Pandemic

 

Non-COVID Development

For sponsors of products in clinical trials that are not directly connected to the COVID-19 response, the global regulatory agencies have issued numerous guidance documents related to the conduct of trials which are outlined in the blog posts below:

 

Regulatory Agency COVID-19 Sites and Guidance On Clinical Trials During COVID-19 Outbreak

 

 

United States |  FDA

 

Canada | Health Canada

 

Europe | EMA

 

United Kingdom | MHRA

FDA Guidance on Conduct
of Clinical Trials of Medical
Products during COVID-19
Pandemic

 Management of clinical
trials during the COVID-19
pandemic: Notice to clinical
trial sponsors		 Guidance on the
Management of Clinical
Trials during the COVID-19 (Coronavirus) pandemic		 Managing clinical trials
during Coronavirus
(COVID-19)

 

Let Us Help You Maintain Trial Integrity 

We understand that the stakes are high no matter where you are in your development program. The stress, anxiety and uncertainty about ongoing,
new, or COVID-19-related clinical programs is overwhelming. We have the agility and scientific-minded experts to help you navigate these uncertain
times.   Schedule an introduction by completing the form below:
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