Quality Systems

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

Oxford/AstraZeneca Vaccine Granted Emergency Use Approval in UK

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

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 targeting websites that market untested CBD products as medical treatments.

FDA Sends Warning Letters Citing Illegal Promotion of CBD Products

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

Compounder Receives FDA Warning Letter

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

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation. 

Second COVID-19 Vaccine Granted EUA, Ships for Immediate Use

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

FDA Publishes Guidance on CRLs Response Timelines during Pandemic

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 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 

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

Regulatory Oversight and Compliance