Topic

Videos

The use of artificial intelligence is facing harder questions of governance and data quality, and regulators in the United States and the European Union are streamlining pathways to market. 

PharmTech Weekly Roundup—July 17, 2026

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.

Articles

The future of compliant AI is not better content generation. It is better control over what happens next.

Can Governance-by-Design Make AI Compliant in Pharma? (Part II)

FDA finalizes bioequivalence guidance for topical corticosteroids and new meeting rules for OTC monograph drug sponsors, replacing a 1995 standard.

The Implications of the FDA’s New Finalized Guidance Documents

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, explain a company’s regulatory affairs department is subject to inspections by regulators and should, therefore, be prepared.

Ask the Expert: Drug Approval Submissions

Jeffrey C. Mocny, PhD, is vice president of Regulatory Strategy at Abzena.

Anna McMahon is director of Regulatory Affairs at Cellares.

Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

Using Risk-Based Quality Frameworks to Fast-Track Biopharma Development: A Q&A with Abzena’s Jeffrey C. Mocny and Cellares’ Anna McMahon

FDA proposes a hub-and-spoke manufacturing registration rule and approves three drugs for multiple myeloma, IgA nephropathy, and bladder cancer.

FDA Activity Round Up – July 2026

EMA and EISMEA have formalized their cooperation through a work program aimed at helping small biopharma and medtech innovators engage with EU regulatory requirements earlier in development, potentially reducing late-stage manufacturing and quality problems for complex modalities.

EMA and EU Innovation Agency Deepen Ties to Speed Up Drug Development

A proposed rule by the agency would create a streamlined registration pathway for advanced distributed manufacturing establishments. 

The FDA Moves to Modernize Drug Manufacturing Registration

FDA approves subcutaneous isatuximab-irfc for multiple myeloma, backed by trial data showing efficacy comparable to IV dosing across three regimens.

The Implications of Isatuximab-irfc’s FDA Approval for Multiple Myeloma

Greater accountability and resilience across drug development and manufacturing are key goals for regulators and industry.

Quality Systems