Quality Systems

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

FDA approval rate speeds up despite COVID-19 complications.

FDA Ends 2020 with High Drug Approval Rate

Agnes Shanley is senior editor of Pharmaceutical Technology.

During the COVID-19 pandemic, when inspectors cannot visit sites directly, FDA is relying on other global inspection reports and remote document review, yet does not consider them equivalent to on-site inspections. Manufacturers await more clarity. 

FDA Inspections Remain Stalled During the COVID-19 Pandemic

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Positive regulatory developments are aiding the growth of the cannabis pharmaceuticals market, but more clinical data are needed to break the stigma and bring science to the fore.

The Budding Field of Cannabis Pharmaceuticals

EMA’s SPOR implementation guide version two is expected to be published soon, starting the countdown for companies to ensure their data-based submissions are compliant.

Coming Up to ISO IDMP Standards

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

The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.

Pandemic Control to Shape Biopharma in 2021

Sean Milmo is a freelance writer based in Essex, UK.

The recently published European pharmaceutical strategy is being seen as an opportunity to strengthen medicines regulation in the region.

Strategizing for Strength in EU Pharma 

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

Updating the quality technical agreement will clarify any expectations and limitations, says Siegfried Schmitt, vice president, Technical at Parexel.

Now is the Time to Update the Quality Technical Agreement

Feliza Mirasol is the science editor for 

The number of recommendations for European marketing authorization of human medicines saw significant increase in 2020 over the previous year.

EMA Marketing Authorization Recommendations Rise in 2020

Commissioner Stephen Hahn evaluates the agency’s response to COVID-19 and how it affected non-COVID related initiatives in 2020.

FDA Commissioner Takes a Look Back at 2020

FDA sent a warning letter to Clientele for CGMP violations at the company’s Sunrise, FL facility that included a lack of an adequate quality unit.

Regulatory Oversight and Compliance