Quality/GMPs

A holistic approach to validation and quality assurance is essential.

The industry is moving beyond cleaning’s “low tech” image to embrace science-based limits and statistical approaches to control.

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

After a difficult year, biopharma 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.

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

The guidelines are part of the independent control of pandemic COVID-19 vaccine batches.

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.

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

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

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.

Successful migrations require careful planning to meet business needs and maintain data integrity.

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Complex manufacturing processes pose challenges for final product inspection needed to ensure product integrity at commercial launch.

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Resolving drug shortages starts with identifying the source of the problem.

Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.

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.

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.

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

FDA issued guidance for applicants that must report annually on the status of postmarketing studies and clinical trials under section 506B of the FD&C Act.