Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|March 15, 2021
- BioPharm International-03-15-2021
- Volume 2021 eBook
- Issue 1
Resources, Guidelines, and Guidance Documents Directory
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Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
Articles in this issue
over 5 years ago
It Takes a Bio/Pharma Villageover 5 years ago
Collaborative Efforts Address Key Data Integrity Challengesover 5 years ago
Can FDA Reinvent Inspections?over 5 years ago
Growing Pipeline of Antisense Oligonucleotides Prompts Guidanceover 5 years ago
Gene Therapies Target Neurodegenerative Diseasesover 5 years ago
A Real-World Approach to Evaluating Cleanroom Garmentsover 5 years ago
FDA 2021 Guidance Agenda Sees Focus on GenericsAdvertisement
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A Treasury proposed rule would restrict certain US investments in biotechnology in China and other countries of concern, raising questions about how cross-border licensing and joint venture deals will be treated.
Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.
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