Quality Systems

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss EMA’s revised guidelines on data protection in marketing authorization applications.

The PharmTech Group interviewed Edwin Stone, CEO of Cellular Origins, about the impact of the changing political landscape on the pharmaceutical industry.

The policy announced by Commissioner Martin A. Makary, MD, will not preclude employees of regulated companies from presenting their views to committees, and rare exceptions will be allowed.

The recombinant vaccine, under the brand name Vimkunya, is recommended for persons age 12 and older who are traveling to a country or territory where there is a chikungunya outbreak.

Calculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the impact of the post-COVID-19 world on the pharmaceutical industry and how that has shifted the talent pool.

SkyCell is working with Microsoft to incorporate SkyCell’s AI-powered supply chain solution into Microsoft Teams and Copilot.

Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Michael Franco, global sales director at PSG Biotech, spoke with the PharmTech Group at INTERPHEX 2025 about recent advancements in pharmaceutical flow sensor technology.

Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.

Pharmaceutical Technology® spoke with Krishna Kanumuri, CEO of Sai Life Sciences, about which trends from 2024 will carry over and impact the bio/pharma industry in 2025.

Josh Hoerner, general manager of Purisys, provides his perspective on FDA’s recommendations for acceptable intake limits for N-nitrosamine impurities.

New TCR-T cell therapies look promising in the treatment of haematological and solid tumours.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

The Act is the European Union’s plan to avert drug shortages.

Christian Cobaugh, Eswar Iyer, and Vincenzo Antignani go behind the headlines to discuss a mixture of investment trends, policy realignments, trade and stock recalibrations, and an apparent crusade against vaccines both new and old.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.