Search results for " regulators"
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Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
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EMA Collaborates with HTA Assessment Networks
An European Generic Medicines Association (EGA) survey of national regulators in the EU pinpointed a number of obstacles to the uptake of biosimilars, including a perception of biosimilars being infer…
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Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
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State of Quality and Compliance in the Biopharmaceutical Industry
When a quality failure happens, regulators will demand the changes and the associated time and cost to accomplish these improvements will be much higher.
Economic drivers
The recent econ…
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Essentials in Establishing and Using Design Space
Intended design space and use should be clearly communicated to regulators. FDA generally welcomes discussion on design space with applicants so be sure to discuss the design space and submission logi…
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Biosimilars Development and Supply: How Complex Can the Process Be?
As the complex requirements of manufacturing biologics are manifold, it is important that biomanufacturing companies adopt quality-by-design principles.
Countries around the world face a gro…
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Milestones and Moderate Progress in 2012 Drug Approvals
However, it was assessed and approved in the US as an original biologics license application (BLA), because a biosimilar pathway was not available to the sponsor at the time of submission to the regul…
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The Future of Biopharma
What the industry's future holds and what needs to be done to get there.
The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation …
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
Resource
Parenteral Drug Association
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded i…