Process Validation

Best practices to strengthen supplier quality management.

Comparative effectiveness poses challenges for drug manufacturers.

A new strategy to streamline vaccine development and oversight.

Too many REMS cause headaches for doctors and the industry.

What small biotechs need to know about quality management systems.

Plant closures, product recalls prompt FDA re-evaluation of GMP enforcement efforts.

By identifying and eliminating non-value-added activities, drug manufacturers can avoid falling into the same cost-traps in the future.

More information may be available on drug approvals, prices, and research to expand public understanding of regulatory policies.

International outsourcing and rising theft spur regulatory action and manufacturer oversight.

Broader benefits and biosimilars will offset hefty fees and discounts while preserving R&D incentives.

The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.

An effective CAPA plan provides a mechanism for responding to the unexpected.

The new Sentinel system aims to expand access to data on medical product safety and patient effects.

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.

How will implementing Quality by Design strategies affect your compliance status?

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.

The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.

Heightened attention to product safety issues is slowing the approval process for new therapies.

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.

Pressures to reduce healthcare spending generates proposals to spur competition, cut costs.

A culture of quality that emphasizes business objectives, risk management, and the informed application of technology can improve compliance.

The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents.

Agency officials promise swift action against violators of drug safety and quality regulations.

New expression systems compete for attention.

Use Lean techniques to improve manufacturing compliance

Authorities are pushing for CE; manufacturers prefer to focus on value.

The FDA is poised to gain more authority and resources to ensure product quality.

The 45 comments submitted raised concerns about legacy products and ongoing process monitoring.