Regulatory Watch

Companies can use metrics as a tool to help drive positive change and quality process improvements.

An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

FDA faces budget crunch; Supreme Court hears key cases

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

Vaccine development is benefiting from manufacturing advances and support for global health.

Prosecutors and regulators challenge manufacturing quality failings likely to cause patient harm.

White House and Congress likely to struggle over funding for bio/pharmaceutical regulation.

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

The promise of the Generic Drug User Fee Amendments of 2012 is to end multiyear reviews of new generic drugs and the ever-growing queue of pending applications.

Import controls and risk strategies aim to promote quality and spur new drug development.

Import controls and risk strategies aim to promote quality and spur new drug development.

A Q&A with FDA Deputy Commissioner Deborah Autor.

New legislation, government programs aim to bolster drug discovery and reduce regulatory hurdles.

Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.

Soaring opioid use creates challenges for new drug development and supply-chain control.

Social media use raises questions about applying old standards to new information technology.

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

Added responsibilities and outside concerns prompt overhaul of agency's structure.

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.

Manufacturers fund research and reduce prices to tackle diseases.

PDUFA renewal legislation sets stage for new policies affecting revenue, resarch, and oversight.

Rising imports and overseas production spur realignment of enforcement.

Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.

Industry struggles to curb drug abuse, diversion, and disruptions in supply.

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.