Pharmaceutical Quality Resources
FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.
Purdue reaches $8B settlement on federal opioid charges—but will it ever pay that amount?
Planes, trucks and ultracold boxes: Pfizer preps massive COVID-19 vaccine distribution effort
FDA blasts another U.S. drugmaker for faulty quality controls on now-recalled thyroid meds
Does Roche's Actemra work in COVID-19? New studies once again paint mixed picture
Novel Drug Approvals for 2020
The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public
Biogen, amid Spinraza and Tecfidera woes, could weigh cost cuts if aducanumab fails: execs
Pfizer could haul in $3.5B in 2021 from COVID-19 vaccine: analyst
Eli Lilly may face FDA warning letter after recent inspection at COVID-19 antibody plant found more issues: report
FDA’s Technology Modernization Action Plan Accelerates the Path to Enhancing and Promoting “People First” Public Health
FDA’s TMAP is the blueprint for modernizing our IT systems. TMAP enables technology and data to innovate our regulatory mission and critical functions and empower our workforce to be as nimble and up-to-date as the products we regulate.