How QbD Is Changing the Drug Approval Process

How will FDA's commitment to Quality by Design (QbD) influence the drug approval process? It's a matter of debate, but Russ Somma, founder of SommaTech, a respected drug development consulting company, shares some keen insight with PharmExecBlog. FDA's decision to do away with "approvable" and "nonapprovable" letters for new drug applications will no doubt cause confusion and hardships in the short term, Somma says, but the move is in the spirit of QbD--putting the onus on the drug manufacturer to build efficacy and safety into a product from day one--and is therefore consistent with FDA's recent quality- and science-based initiatives. PWT