BioPharm International, Regulatory Sourcebook October 2021

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.

Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback.

Responsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices.

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

Industry representatives sound off on FDA’s FARS report, released in January this year.