Industry Organizations Assist Pharma During the Pandemic and Beyond
BioPharm International checked in with AAPS, IPEC-Americas, and PDA to get an update on how the organizations are navigating the pandemic and planning for the future.
NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations
Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback.
How Artificial Intelligence Impacts the Global Regulatory Environment
Responsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices.
Selecting the Right CMC Strategy for Biologics
Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.
The Evolving Biosimilar Approach
The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.
Serialization and Aggregation from a Manufacturing Perspective
For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.
The Real Danger of Substandard and Counterfeit COVID-19 Vaccines
Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.
Collecting Industry’s Thoughts on FDA FARS Report
Industry representatives sound off on FDA’s FARS report, released in January this year.
