Regulatory Authority Actions

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.

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

FDA, US Customs and Border Protection, and the US Immigration and Customs Enforcement, Homeland Security Investigations signed a Memorandum of Understanding to prevent illegal drug imports from entering the US through International Mail Facilities.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

FDA published guidance for submitting standardized study data in electronic format.

The agency, in response to an executive order, published a list of essential medicines, medical countermeasures, and critical inputs that should be available at all times in an adequate amount to serve patient needs.

FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.

The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.

FDA sent a warning letter to LEC Custom Products for a variety of CGMP violations including use of inappropriate equipment and processes.