Day: March 18, 2021

Last year between March and December, FDA “reduced the need” for Pre-Approval Inspections (PAI) by more than 50%, and still met almost all its product approval timelines (93-100% of the times), raising the question if these inspections can be reduced for good. The year of the pandemic forced FDA to do an experiment otherwise impossible; … Read more

One year after the pandemic, there is still a critical shortage of laboratory supplies affecting most research activities indirectly. A survey of testing labs by the American Society for Microbiology in January found that supply shortages were affecting almost 50% routine bacterial testing, 35% sexually transmitted diseases, 30% mycobacteria, and almost 20% routine fungal tests. … Read more