Newsletter - October 13, 2016
Are Priority Review Vouchers Really Worth the Hype? May be Not.
The Priority Review Vouchers or PRVs are a much coveted incentive from FDA with an estimated value of over $300 million, but a close review of the case studies shows it may be more hype than benefit to the owners. It has been almost 10 years since the PRV program was implemented and so far 11 of these were awarded; 8 for the development of treatments for tropical diseases and 3 for rare pediatric diseases. Read More
FDA New Inspection Protocol Project: New Improved Way for GMP Audit
Last year FDA’s newly formed Office of Pharmaceutical Quality (OPQ) announced that it would update its GMP inspections process to add risk-based factors whereby sites with higher risk will be given more attention and sites that exceed basic compliance will be rewarded. The program which was named New Inspection Protocol Project (NIPP) would change the regulatory paradigm of GMP inspections by standardizing data gathering during inspections... Read More
Are Priority Review Vouchers Really Worth the Hype? May be Not.
The Priority Review Vouchers or PRVs are a much coveted incentive from FDA with an estimated value of over $300 million, but a close review of the case studies shows it may be more hype than benefit to the owners. It has been almost 10 years since the PRV program was implemented and so far 11 of these were awarded; 8 for the development of treatments for tropical diseases and 3 for rare pediatric diseases. Read More
FDA New Inspection Protocol Project: New Improved Way for GMP Audit
Last year FDA’s newly formed Office of Pharmaceutical Quality (OPQ) announced that it would update its GMP inspections process to add risk-based factors whereby sites with higher risk will be given more attention and sites that exceed basic compliance will be rewarded. The program which was named New Inspection Protocol Project (NIPP) would change the regulatory paradigm of GMP inspections by standardizing data gathering during inspections... Read More
