Quality Systems

The product is being recalled because of Burkholderia cepecia contamination.

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

The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

The COVID-19 pandemic has pushed more pharmaceutical companies and regulators to use new technologies for remote quality audits and inspections.

Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.

USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.

The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future.

After a difficult year, bio/pharma science delivers promising results.

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

A holistic approach to validation and quality assurance is essential.

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.

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

EMA has requested the full data from the Solidarity trial in order to evaluate the marketing authorization of Veklury (remdesivir) in the European Union.

The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.

The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States

AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).

Opposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to EMA for expanded use of the SC formulation of Darzalex.

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.