FDA and EMEA have a Parallel Scientific Advice Procedure – Reminder
Just a reminder that the FDA CBER (centre for biological evaluation and research) and EMEA have a combined scientific advice procedure. It is a pilot programme at the moment and is developed to offer a parallel process to industry.
On September 17, 2004, the EMEA and the FDA agreed to undertake a pilot program to provide parallel scientific advice (PSA). The pilot began on January 1, 2005 and was extended per agreement of both parties on March 13, 2006. For the FDA, this program aligns most closely to pre-IND/end of Phase II meetings. During this pilot, PSA efforts should focus primarily on important breakthrough products. The expected advantages from such interactions are.
- increased dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product,
- a deeper understanding of the bases of scientific advice, and
- the opportunity to optimize product development and avoid unnecessary testing replication or unnecessary diverse testing methodologies.
These meetings are conducted under the auspices of the confidentiality arrangement between the European Commission, the EMEA, and FDA. The complete text of the agreed upon general principles for the pilot can be found at the General Principles EMEA – FDA Parallel Scientific Advice Meetings Pilot Program website.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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