Development

A rigorous cost-benefit assessment can help to chart a cost-effective path forward.

FDA, NIH, and industry seek new strategies to spur drug development and promote access to therapies.

Courts and Congress seek to reshape policies and programs affecting drug costs and access.

Executive management leadership is essential in the effective implementation of QbD.

The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.

As drug shortages make headlines, FDA tests the Sentinel safety system and its effect on healthcare.

Comparing the economic feasibility of a typical glycosylated protein.

FDA prepares for top-level changes while promoting transparency and product safety

An approach to reduce batch time, increase productivity, and decrease costs.

A case study to compare the performances of several types of mixing in disposable bags with stainless steel bioreactors.

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

Changes on Capital Hill create uncertainty for healthcare reform, drug regulation, and biomedical research.

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.

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

Two case studies show how advanced information technologies make process development more efficient.

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.

Formulation strategy is an important consideration when selecting and managing outsourced biopharmaceutical development programs.

Computational fluid dynamics can resolve performance problems.

Computational fluid dynamics is a powerful tool to optimize processes.

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.