Ask the Regulatory Experts
We regularly publish a regulation and compliance Q&A with former FDA officials now consulting at Parexel. Where do these questions come from? You, the readers.
PharmTech regularly publishes common Q&As regarding the regulation and compliance of pharmaceutical development and manufacturing. Questions are answered by former FDA officials, now in consulting roles.
Questions can be sent to ssutton@advanstar.com. All names/submissions will be kept anonymous.
Alternatively, questions can be posted on our LinkedIn Group or sent to us on Twitter @PharmtechGroup.
You can read some of the past Q&As here. We’d love to hear your comments on the advice. Is it useful? Do you have any follow up questions?
Inspections by FDA are on the rise. How can one best prepare?
Can you offer any best practices for change management?
How important is it to respond to an FDA–483 within 15 days?
Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries
May 30th 2025In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
