FDA aims for quality through regulatory science

The FDA has added flesh to the regulatory science document it issued last fall, outlining its vision of how the science might be used to enhance oversight efforts. In a strategic plan issued yesterday, the agency revealed its focus areas.

The regulator says it will support "innovative analytical approaches to improve manufacturing and quality through active research," both internally and with outside partners. It also will look into understanding the effects of continuous versus batch manufacturing on drug quality. In addition, it will investigate manufacturing technologies to determine how they affect product failure rates. And it plans to evaluate the role of excipients and complex dosage forms on product safety, efficacy and quality.

The agency also plans to dig into two state-of-the-art manufacturing strategies--process analytical technology and quality by design. It hopes to discern their impact on manufacturers' ability to maintain quality consistency.

Other items on its list include developing analytical methods to evaluate product quality and creating tests to detect and identify microbial contamination.

The plan represents the agency's current thinking, according to a spokesperson. "But as scientific and public health needs evolve, we will continue to revisit and refine this plan."

- here's the FDA's release
- see the report (.pdf)

Suggested Articles

The cleaning procedures are so poor at a Zydus Cadila plant in India that the FDA says a sampling found 10 different cross-contaminated products.

Mylan is the most recent drugmaker facing the FDA's ire over a tainted API that led to a global recall of "sartan"-based drugs last year.

Merck MSD's $1.2 billion production restructuring has fallen on a site in France, where more than 200 manufacturing and R&D jobs will be swept away.