Quality Systems

Articles

Verquvo is a soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure. 

FDA Approves Merck’s Symptomatic Heart Failure Drug

The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.

AstraZeneca and Daiichi Sankyo’s Breast Cancer Treatment Approved for Use in Europe

A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies. 

FDA Publishes COVID-19 Pandemic Recovery and Preparedness Plan Summary Report 

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

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The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.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

FDA puts applications on hold as the agency limits alternative oversight methods. 

FDA Inspection Shutdown Increasingly Delays Approvals

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

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.

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