Quality/GMPs

 Washington Editor, jillwechsler7@gmail.com.

Articles

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

FDA Under Pressure to Restore “Normal” Drug Inspections

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.

Tevogen Bio Partners with Yale in Regulatory Sciences Program Expansion 

Agnes Shanley is senior editor of Pharmaceutical Technology.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk. 

Prioritizing Cleaning Validation

White House proposal includes measure to make drugs more affordable.

Drug Prices Targeted in Biden Competition Initiative

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

White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

The Value of FDA 483s and Warning Letters

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

FDA Advisory Committees Under Scrutiny

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

FDA Gives Guidance on Development of Breast Cancer Drugs

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

FDA Publishes Guidance on CMC Changes to an Approved Application 

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

Regulatory/GMP Compliance