Quality Systems

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

High price tags threaten to block patient access to potentially life-saving cures and treatments.

FDA Grapples with the Promise and Perils of Gene Therapy

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

Pandemic Alters Policies and Practices for Drug Development and Regulation

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs. 

Pandemic Alters FDA Inspections and Quality Oversight

After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.

Can Califf Bring Clarity and Enhanced Credibility to FDA?

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

FDA Moves to Advance Innovative Excipients

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

FDA to Rely on Real World Data and Evidence for Future Research and Market Approvals

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

Biosimilars Move to Center Stage

CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.

CMA Fines Advanz for Over-Pricing Liothyronine Tablets

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

FDA Prioritizes Vaccine Review and Process Improvements

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production. 

Regulatory Watch