Quality Systems

CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.

The organization’s set of product-specific biologics emerging standards are available on its Emerging Standards Platform for public comment.

FDA instability, staff turnover, and evolving review standards are reshaping drug development. Richard Pazdur, formerly with the FDA, shares what sponsors need to know now.

The new draft guidance allows for the use of publicly available information and established platform knowledge in regulatory submissions for cell and gene therapies that use genome editing in human somatic cells.

This week's news and expert commentary shows that regulatory timelines are tightening, strategic capital is moving into new therapeutic categories, and long-standing operational gaps are demanding real solutions.

PharmTech takes a look back at US and European regulatory news from the month of May 2026.

Dr. Christine Allen, Co-Founder and CEO of Intrepid Labs, and Dr. Andrew Lewis, Chief Scientific Officer of Quotient Sciences, explain how AI can be used in drug development to shorten development timelines.

FDA extends AstraZeneca’s camizestrant's review deadline to assess additional data after its advisory committee failed to reach a majority vote in April.

The CMA will improve Europe’s manufacturing resilience and lead to greater diversification and reduced reliance on single external suppliers.

Pharmaceutical serialization must evolve from regulatory compliance into operational intelligence, addressing hidden failures like exception overload, certificate expiry, and 3PL complexity.

Increased regulatory flexibility for rare diseases, a critical shift toward automated, data-driven manufacturing, and strategic acquisitions in genetic medicine were some of the highlights this week.

Quantum chemistry is accelerating drug discovery AI by providing physics-based, reproducible, and scalable data that encodes molecular reality.

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

Deborah Smook, co-founder and co-owner of TurboFil Packaging Machines, explains some of the challenges involved with prefilled syringe manufacturing.

The FDA replaced acting heads of its drug and biologics centers, deepening leadership instability that raises concerns for pharmaceutical developers.

FDA Commissioner Marty Makary resigns amid agency turmoil, staff exodus, pressure over vaccines, rulings on abortion pills, and vaping rules.

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

Visual inspection injectable products may be enhanced by the utilization of AI to analyze and link data to identify deviations, trends, or irregularities.

Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.

This article provides a statistically defensible and GMP-aligned justification for continued IPC reliance on computed net fill weight when equivalence in mean and variance can be demonstrated.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, discussed trends influencing the design of pharmaceutical manufacturing facilities during a Quick Fire Learning Lab at INTERPHEX 2026.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.