Quality Systems

Rita Peters is editorial director of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.

Articles

Misleading messages contribute to eroding trust in public health agencies.

Fighting the (Dis)Information Pandemic

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

With little more than a month to go until the national election, President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions. 

Trump Health Policies Again Thrust Drug Pricing and Access into the Spotlight

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

FDA Gives Guidance on Geriatric Information in Labeling

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

EMA Endorses Dexamethasone for Use in COVID-19 Patients on Oxygen Therapy

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

EMA Recommends Seven Medicines for Approval

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Oklahoma Facility Given FDA Warning

The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.

FDA Gives Guidance on Manufacturing During COVID-19

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

Career FDA Leaders Say Science Is Agency’s Guide

PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.



PRAC Recommends Marketing Authorization of Ulipristal Acetate be Revoked

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19. 

Regulatory Authority Actions