Complex manufacturing processes pose challenges for final product inspection.

Taking a Closer Look

Transporting large quantities of COVID-19 vaccines pose challenges.

Tracking the Cold Chain

Cleaning’s low-tech image is evolving to science-based limits and statistical approaches. 

Cleaning Validation Embraces Science

Topic

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

Articles

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far. 

Vaccine Rollout Even Worse than Expected

As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA. 

FDA Struggles to Fend Off Further Attacks from Trump Administration

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

FDA Gives Guidance on Gene Therapy for Neurodegenerative Diseases 

The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

Despite Pandemic, FDA Ramps Up New Drug Approvals

FDA puts applications on hold as the agency limits alternative oversight methods. 


FDA Inspection Shutdown Increasingly Delays Approvals

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

EC Authorizes Moderna’s COVID-19 Vaccine for European Roll-Out

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

FDA: Stick with Approved EUAs for COVID-19 Vaccines

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Clear understanding of what exactly the biomolecule entails is essential.

Using Protein Characterization to Support Regulatory Submissions

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

Pandemic Control to Shape Biopharma in 2021

Siegfried Schmitt, PhD, is principal consultant withÂ PAREXEL, Siegfried.Schmitt@parexel.com.

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

Quality/GMPs

Taking a Closer Look

Tracking the Cold Chain

Cleaning Validation Embraces Science