Quietly issued internal Compliance Program guidance on post-approval inspections suggests official action could be indicated when it turns out some “established conditions” are missing from applications. Whether the rate of these inspections will need to increase in the wake of the pandemic, particularly as applications for complex dosage forms and new manufacturing modalities multiply, remains to be seen.

Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages. 

Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages. 

Alphabet soup of policy developments includes an answer to subjectivity in risk assessment, the unexpected industry benefit of the FDA’s quality rating plans, and some advice on testing for impurities that could be controlled substances.

CEO reacts to FDA untitled letter in interview, saying Valisure is no subpar GMP lab. Rather, it provides independent drug quality testing for buyers and could be part of a broader solution for steering them toward the highest quality drugs.

FY2023 appropriations language requires HHS Secretary to designate advanced manufacturing technologies for expedited review, and to follow up with advice and meetings that could help move things along.