News Focus
News Focus
icon url

Meowza

01/05/21 9:00 AM

#318134 RE: rafunrafun #318114

Yes, it's a bullstuff agenda, I agree.

I particularly dislike indulging such loose tolerances for generic strength (80%??), there is zero reason that amount of variance is needed for a manufacturing process. Also I'm tired of mass recalls every other month because the imported generic version might give millions a mild form of cancer.
icon url

shadolane

01/05/21 11:04 AM

#318154 RE: rafunrafun #318114

The FDA should not compromise on this topic. People believe they are getting equivalency and are not.

This is not unique to pharma either. Critical components that are of inferior material and/or processing could result in the wings falling off a plane. Maybe the FDA should think in those terms when they consider being liberal with equivalency.