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EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

EMA Ends Rolling Review of CureVac’s COVID-19 Vaccine Candidate

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

MHRA Awards ‘Innovation Passport’ to CellResearch for Stem Cell Therapy

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

FDA Approves ChemoCentryx’s Tavenos

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.

FDA Grants AstraZeneca's Tezepelumab Orphan Drug Designation 

FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

FDA Grants Emergency Use Authorization for OTC COVID-19 Test

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine. 

EMA Approves Manufacturing Site for Janssen COVID-19 Vaccine

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

EMA Recommends Boosters of Pfizer and Moderna COVID-19 Vaccines for Some Individuals

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

Application for COVID-19 Treatment Submitted to EMA 

Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.

“Waive Vaccine Patents” is Projected onto Hotel Hosting UK’s Annual Conservative Conference

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

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

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