Day: June 2, 2022

It took about 11 months from the beginning of the world-wide spread of Covid-19, in Jan 2020, to getting available an exceptionally effective vaccine to it. But this breakneck speed of development is an exception and should not be expected to be repeated for all other diseases and infections. The conventional wisdom of needing about … Read more

A report on inspectional findings during GCP audits by FDA and EMA inspectors found that both regulators found similar issues 9 out of 10 times. The findings of this report, published jointly by the FDA and EMA, support sharing of audit findings between the two agencies to reduce the burden of direct inspections for both. … Read more