Quality Systems

FDA approval rate speeds up despite COVID-19 complications.

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.

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.

Traditional biologic-based testing methods may need an upgrade to properly test newer therapeutic modalities.

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

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

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

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

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

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

Sunstar Americas is expanding its voluntary recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12% products because of Burkholderia lata contamination.

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.

The agency is targeting websites that market untested CBD products as medical treatments.

Customceutical Compounding was sent a warning letter by FDA after investigators found deficiencies in the production of sterile drug products.

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.

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

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

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

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

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

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

Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.

Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.

Success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the United States government and public health organizations around the world.

Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.

The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.

Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.