PRODUCT DEVELOPMENT PROTOCOL REENGINEERING PROPOSAL SUGGESTS "REAL-TIME" REVIEWS OF CHANGES DURING STUDIES; PMA REENGINEERING TEAM TO BE FORMED
This article was originally published in The Gray Sheet
FDA expects "real-time" reviews during the product development protocol process will help eliminate obstacles that prevented effective use of the PDP approach in the past.
You may also be interested in...
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.