Search results for " regulatory"
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Gowning Practices Provide Clues to cGMP Compliance
This concept is broadly embraced across the globe and promulgated by drug regulatory agencies, such as FDA in the United States, the European Medicines Agency in the European Union, and the World Heal…
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Q&As with Industry Leaders
…nd Efficient Biologic Drug Development
Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates
Future Downstream Process Development So…
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Best Practices in Adopting Single-Use Systems
Another positive factor has been suppliers’ increased commitment to providing a robust regulatory package. Vendors have taken on the burden of documenting their products’ suitability and safety, which…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Because the non-EEA authorized product would have to follow similar scientific and regulatory standards as those of the EMA, it would have to be in a country that is a member of the International Conf…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
This binary designation was usually determined during early development for the purposes of regulatory filings, relying heavily on scientific judgment and limited laboratory studies.
Wi…
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Operational Excellence: More Than Just Process Improvement
Life-sciences organizations will need such hardy cultures of quality to withstand stepped-up regulatory scrutiny. FDA Commissioner Margaret Hamburg told participants at the Annual Meeting of the Gener…
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Biosimilars Development and Supply: How Complex Can the Process Be?
A recent report (3) from the European Commission looking at Europe’s strong regulatory and commercial foundation for biosimilars found that biosimilars are improving competition in Europe and increasi…
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Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
Globally, GS1 works with pharmaceutical manufacturers, wholesalers, distributors, retail pharmacies, hospital dispensaries, trade associations, and regulatory agencies to help advance track-and-trace …