Day: September 8, 2022

Last year, the most common FDA 483 finding from inspections of drug manufacturing sites was non-compliant handling of deviation investigations and inadequate quality unit oversight. Inadequate CAPA, data integrity issues, and deficiencies in training of personnel wrapped up the top 5 major findings by FDA inspectors. The annual report on the GMP compliance in the … Read more

An independent study found that more than 76% of the drugs approved under the accelerated approval pathway (AAP) in the US did not demonstrate any additional therapeutic benefits compared to the previously available treatment options for the same indication. Also, the US FDA approved nearly three times as many drugs under this pathway compared to … Read more