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

Shannon Parisotto, MBA, is the corporate senior vice president of Charles River Laboratories.

Articles

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.  

Toxicology: Ensuring Drugs are Safe for People

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

The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.

Biden Pandemic Plan Highlights Vaccine Access and Therapeutic Development

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The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.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

Now is the Time to Update the Quality Technical Agreement

President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic. 

Pandemic Relief Legislation Provides Economic Assistance, Boosts Federal Budgets

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

EMA to Hold its Second Public Meeting on COVID-19 Vaccines

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

CHMP Gives Positive Opinion for Pfizer-BioNTech Vaccine

The guidance provides information on review timelines during the COVID-19 pandemic.

FDA Publishes Guidance on CRLs Response Timelines during Pandemic

The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.

FDA Issues Guidance on Complex Innovative Trial Designs 

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

FDA Advisors Recommend Moderna’s COVID-19 Vaccine

The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.

FDA Answers COVID-19 Vaccine Questions

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

Quality/GMPs

Taking a Closer Look

Tracking the Cold Chain

Cleaning Validation Embraces Science