
- BioPharm International-03-15-2021
- Volume 2021 eBook
- Issue 1
FDA 2021 Guidance Agenda Sees Focus on Generics
The agency’s focus appears to be on generic drugs for the upcoming year.
For the bio/pharmaceutical industry, 2020 was a challenging year, as industry worked to develop and manufacture vaccines and treatments for the COVID-19 pandemic. Despite an increased workload and travel restrictions precipitated by the pandemic, FDA continued to meet goals and approve new drug products. As the effects of the pandemic continued in the first quarter of 2021, FDA’s two bio/pharma sectors, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), have announced their guidance agendas for the year.CDER has plans for new or updated guidance documents in a variety of areas, especially for generic drugs and procedural updates; CBER is focused on tissues and advanced therapies.
About the author
Susan Haigney is managing editor of BioPharm International.
Article Details
BioPharm International
eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 39–41
Citation
When referring to this article, please cite it as S. Haigney, “FDA 2021 Guidance Agenda Sees Focus on Generics," BioPharm International Regulatory Sourcebook eBook (March 2021).
Articles in this issue
over 4 years ago
It Takes a Bio/Pharma Villageover 4 years ago
Collaborative Efforts Address Key Data Integrity Challengesover 4 years ago
Can FDA Reinvent Inspections?over 4 years ago
Growing Pipeline of Antisense Oligonucleotides Prompts Guidanceover 4 years ago
Gene Therapies Target Neurodegenerative Diseasesover 4 years ago
A Real-World Approach to Evaluating Cleanroom Garmentsover 4 years ago
Regulatory and Standard Setting Organizations DirectoryNewsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.