Quality Systems

AI can turn medical device risk management into a continuous signal.

This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.

The EU is focused on strengthening supply-chain resilience, avoiding medicine shortages, simplifying regulations, and implementing new approach methodologies.

In commercial tablet or capsule operations, validation helps protect the site’s ability to produce, release, and supply product without repeated disruption. This article discusses validation as a technical control system that supports manufacturing continuity.

This article explains the 4 shifts enabling faster, lower-risk, commercially successful biologics technology transfer.

Silvia Forroova, director of Partnerships & Sustainability at CPHI, and founder of the CPHI Sustainability Collective, provides a preview of the new Sustainability Summit at CPHI Milan 2026.

The FDA approves zilganersen, the first disease-modifying Alexander disease therapy, offering rare disease developers a trial design and RNA delivery model.

The finalists for the 2026 CPHI Pharma Awards span 15 categories including API development, digital transformation, manufacturing, supply chain, sustainability, and leadership, with winners revealed October 6 at CPHI Milan.

Nitrosamine control is about understanding why nitrosamines form, where they may form, and how to prevent their formation.

Four FDA approvals in the areas of HIV, diabetes, autoimmune disease, and COVID-19 vaccines came in a flurry in late August 2026.

Agentic AI changes the question from what a model can produce to what a system is allowed to decide.

FDA approves Rasonque (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer, validating RAS(ON) inhibition for future drug development.

FDA priority review of Jemperli for biomarker-defined rectal cancer signals capacity, supply chain, and global filing shifts for manufacturers.

REGENXBIO's RGX-121 faces an FDA clinical hold after asymptomatic spine MRI findings, highlighting long-term imaging surveillance for CNS gene therapies.

The FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSDIa, raising manufacturing and post-market monitoring questions.

The FDA approves first therapy shown to reduce new bone lesions and flare-ups in fibrodysplasia ossificans progressiva (FOP), based on a 63-patient trial using CT-scan efficacy endpoints.

The Trump administration nominates Heidi Overton for FDA commissioner amid leadership instability, raising questions for drug developers on review timelines and oversight.

FDA grants Priority Review to Teva's ecopipam new drug application, backed by phase 3 data. Ecopipam is a first-in-class D1 receptor therapy for pediatric Tourette syndrome.

Postmarketing governance must be evidenced across the full life cycle—design, validation, and live monitoring—not documented once and assumed to hold.

LEO Pharma acquires dersimelagon from Tanabe Pharma for up to $435M, adding a late-stage oral rare dermatology asset under FDA review.

This episode of PharmTech Explained discusses how China's biotech surge is reshaping US drug licensing, manufacturing control, and FDA data trust, the key shifts pharma professionals must track.

Glenn Herring, Halo Pharma, discusses its new sterile fill-finish platform: Groninger/SKAN tech, GMP design, and 2026 qualification timeline.

Lee Karras, CEO, Halo discusses the company's new sterile fill-finish platform, Apotex partnership, and injectable onshoring strategy.

EMA’s draft GMP Annex 22 sidelines LLMs in critical manufacturing, fueling a push for risk-based guardrails and human accountability.

Glenn Herring, Halo Pharma, details the CDMO's new sterile fill-finish platform, Groninger/SKAN tech, GMP/Annex 1 design, and 2026 qualification timeline.