Regulatory Authority Actions

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.

FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner.

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.

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.

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

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.

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

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.

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

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.

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

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

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

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

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

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

Due to a packaging error, the company is voluntarily recalling one lot of sildenafil 100 mg tablets for the treatment of erectile dysfunction and one lot of trazodone 100mg tablets for the treatment of major depressive disorder.

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

The European Medicines Agency has launched a full investigation into a cyberattack.

The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.

After a difficult year, biopharma science delivers promising results.

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.