Quality Systems

Renato Rjavec is director of product management at Amplexor Life Sciences.

Articles

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

What DADI Means for the Pharmaceutical Industry

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children

Cheryl Barton is director of PharmaVision, 

On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.  

In-Vitro Diagnostic Regulation

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

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

FDA and Industry Prepare for Transition from Emergency Use Authorizations

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

ENHERTU Granted Breakthrough Therapy Designation in US

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel. 

FDA Grants RMAT Designation to Autolus’ CAR-T Cell Therapy

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

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.


Which Batch Size for Validation and Stability Studies?

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children. 

Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.

Tremelimumab Accepted Under Priority Review in the US

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

Regulatory Oversight and Compliance