Skates1616
Joined 3 years ago
Karma
29
Submissions
6
Member since
Dec 12
Joined 3 years ago
The real challenge lies in the expectations the FDA has set for manufacturing. Over time, the regulatory space has been heavily influenced by academic-driven theoretical scenarios for microbiological contamination. While well-intentioned, these theoretical risks often drive overly stringent requirements that don’t always reflect real-world manufacturing risks.
As a result, it’s becoming prohibitively expensive to manufacture drugs for the U.S., especially sterile injectables.
And truly it gets worse every year…
Hopefully this now gets more support with the antics that Twitter has pulled with these 3rd party clients.
You won’t get a title without making the payments…