Topic

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.

Videos

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

Ask the Expert: Questions about Real-World Evidence and Supply Chain Security

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

The FDA draft guidance "Considerations for Complying with 21 CFR 211.110" raises points to consider regarding drug products made using advanced manufacturing, batch uniformity, drug product integrity, and how manufacturers can incorporate process models into control strategies.

Stakeholders React to FDA's Push for Quality, Integrity, and Uniformity

The dispute shines a light on the vulnerability of long-established drugs to renewed safety scrutiny: Even when causal evidence is lacking, observational findings can influence policy and public perception.

Acetaminophen and Autism: Industry Impacts of the White House Statement

Advancements for novel cancer therapies are booming. This video takes a look at some of the latest efforts in the cancer research and therapy arena.

Converging Fronts of Cancer Treatments

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

EMA states the new variations guidelines will streamline lifecycle management and make processing variations quicker.

European Commission Streamlines Drug Lifecyle Management

Feliza Mirasol is the science editor for 

CDC panel shifts vaccine policy by discouraging combined MMRV shot for young children due to increased febrile seizure risk.

CDC Panel’s Vote Separates MMRV Shot and What That Means

Pharmaceutical Technology® spoke with Todd Sprouse, associate director, Analytical Services, and Erik Feldmann, PhD, principal technical advisor, Client Solutions & Proposals, both with Cambrex, to find out more about the challenging situation.  

The Continuous Challenge of Nitrosamines

Misleading promotions of GLP-1 and compounded semaglutide products are drawing renewed regulatory scrutiny over risk disclosure and safety messaging.

Lilly, Novo, Hims Get FDA Warnings About Misleading Drug Communications

Bram Baert, global head of Regulatory Affairs at Lonza CHI, gives his perspective on the impact of the EC’s decision on the use of TiO2 in drug products.

The Impact of Europe’s Decision on the Use of Titanium Dioxide 

Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, joins PDA CEO Glenn Wright and Melissa Seymour, Executive Vice President, Global Quality, Eli Lilly and Company, to talk about the regulatory and quality topics discussed at the 2025 PDA Regulatory Conference. 

Quality Systems