The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Articles|December 21, 2006
US District Judge's Order Granting Preliminary Injunction in RxUSA Wholesale, et al, v. FDA
Author(s)Pharmaceutical Technology Editors
US District Court for the Eastern District of New York Judge Joanna Seybert's Dec. 11, 2006 Order granting a preliminary injunction in RxUSA Wholesale, et al, v. FDA, barring FDA from enforcing some drug pedigree rules.
Advertisement
Advertisement
Related to this article
Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
Vibha Jawa, PhD, chief scientific officer at EpiVax, discusses the limitations of current preclinical testing approaches and how new approach methodologies can strengthen drug development.
Pauric Bannigan, Intrepid Labs, explains how physics-informed machine learning aids formulation and why regulators still want experimental data.
Advertisement
Advertisement