Quality Systems

FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.

The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.

The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.

FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.

Communications and planning are crucial to recovering from supply, operations, and facility disruptions.

As equipment evolves and use of PAT increases, DOE is becoming an integral part of upstream bioprocess development.

Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.

Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.

The agency sent warning letters to 15 companies for illegally selling cannabidiol products.

The agency sent a warning letter to Torrent Pharma after an inspection found violations of current good manufacturing practices that included a failure to thoroughly investigate batch failures.

The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.

The approval of Givlaari (givosiran) is the first for treatment of acute hepatic porphyria, which results in the buildup of toxic porphyrin molecules during the production of heme.

The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.

Roche’s ADC, Kadcyla, has been recommended for approval in the EU for for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment.

The recent approval by FDA of Vumerity (diroximel fumarate), a new drug for treating multiple sclerosis, has a triggered a $150-million milestone payment from Biogen to Alkermes.

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.

In a statement, Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, highlighted the agency’s efforts to enhance the efficiency of postmarket drug safety surveillance.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

An effective quality control unit is independent from manufacturing and ensures current standards are followed.

FDA readies more efficient oversight processes while advancing collaboration with Europe.