Quality Systems

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

7-OH and the leaf of the kratom plant are not analogous, but as the former is a derivative of the latter, it has opioid-like qualities that make its susceptibility to abuse concerning.

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.

The authors performed interference and enhancement testing using a formulated alkaline and acid cleaner, as well as common biopharmaceutical process residues.

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Artificial intelligence and machine learning can help identify complex patterns.

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

NIBRT, Firefinch, and eg technology will join the center, adding to its collective of healthcare innovators.

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.

The new lab will be used to develop and scale innovations for the production of medicines and to help secure the supply chain.

EMA has published recommendations to address potential radiopharmaceutical shortages.

Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

Teva’s investigational monoclonal antibody, TEV-53408, has been designed for use in adults with celiac disease, for which a strict and lifelong gluten-free diet is currently the only treatment.