Quality Systems

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Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

Kapruvia Approved by EC for Treatment of Pruritus

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

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives. 

Congress Presses FDA on Key Policies and Operations 

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

FDA Grants Quanterix Plasma Test Breakthrough Device Designation

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine. 

Migraine Treatment Granted Marketing Authorization by European Commission 

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children

Cheryl Barton is director of PharmaVision, 

On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.  

In-Vitro Diagnostic Regulation

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

FDA and Industry Prepare for Transition from Emergency Use Authorizations

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

ENHERTU Granted Breakthrough Therapy Designation in US

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel. 

FDA Grants RMAT Designation to Autolus’ CAR-T Cell Therapy

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children. 

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