10.21.2020

Pharmaceutical Quality Resources

FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance documents, and compliance programs.
10.21.2020

Purdue reaches $8B settlement on federal opioid charges—but will it ever pay that amount?

Purdue reaches $8B settlement on federal opioid charges—but will it ever pay that amount? kblankenship Wed, 10/21/2020 - 11:54
10.21.2020

Planes, trucks and ultracold boxes: Pfizer preps massive COVID-19 vaccine distribution effort

Planes, trucks and ultracold boxes: Pfizer preps massive COVID-19 vaccine distribution effort esagonowsky Wed, 10/21/2020 - 11:28
10.21.2020

FDA blasts another U.S. drugmaker for faulty quality controls on now-recalled thyroid meds

FDA blasts another U.S. drugmaker for faulty quality controls on now-recalled thyroid meds kblankenship Wed, 10/21/2020 - 10:30
10.21.2020

Does Roche's Actemra work in COVID-19? New studies once again paint mixed picture

Does Roche's Actemra work in COVID-19? New studies once again paint mixed picture aliu Wed, 10/21/2020 - 10:02
10.21.2020

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
10.21.2020

Biogen, amid Spinraza and Tecfidera woes, could weigh cost cuts if aducanumab fails: execs

Biogen, amid Spinraza and Tecfidera woes, could weigh cost cuts if aducanumab fails: execs esagonowsky Wed, 10/21/2020 - 09:54
10.21.2020

Pfizer could haul in $3.5B in 2021 from COVID-19 vaccine: analyst

Pfizer could haul in $3.5B in 2021 from COVID-19 vaccine: analyst arlene.weintraub Wed, 10/21/2020 - 09:14
10.21.2020

Eli Lilly may face FDA warning letter after recent inspection at COVID-19 antibody plant found more issues: report

Eli Lilly may face FDA warning letter after recent inspection at COVID-19 antibody plant found more issues: report kblankenship Wed, 10/21/2020 - 08:46
10.21.2020

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.