Search results for " regulators"
Article
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
…
Article
Early Communication with Regulators is Essential for SMEs
The importance of early dialogue with regulators
Companies are encouraged to contact the agencies as early as possible during the drug-development stage to ensure that their manufacturing proces…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Modernizing manufacturing approaches for pharmaceuticals, such as through QbD, continuous manufacturing, and/or PAT, has the potential to benefit industry, regulators, and patients. Already, there hav…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
At the same time, the regulators required vaccine trials to test thousands of patients to assure the public of the safety and viability of these new preventives. Vaccine experts at the Center for Biol…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Differences in a drug that go beyond the range of variability in the reference product, particularly when they have clinical significance, are likely to be rejected as being a biosimilar by regulators…
Article
Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expandi…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
But what a lot of people don't realize is while different regulators—the EU, FDA, the Therapeutic Goods Administration down in Australia, or whatever regulator it may be—while they do not offer and ap…
Article
Good Manufacturing Practices: Challenges with Compliance
Muzzin (Emergent): Opportunities exist in harmonizing, sharing, and training of regulators, innovators, and manufacturers on how to interpret and operate under CGMPs. Compliance and quality should be …
Article
A Look into the Future of Biopharmaceutical Quality
To gain perspective on what the future holds for biopharmaceuticals and how the industry and regulators will address quality going forward, BioPharm International spoke with Anthony Newcombe, principa…
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
In addition, academia plays a key role in conducting fundamental research and pioneering new technologies; suppliers develop and commercialize new technologies; and regulators ensure that new advancem…