Search results for " regulatory" in Articles / App Notes
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The need of global regulatory alignment
QbD is now at a “critical step” between regulatory support for its concepts and a much deeper implantation of its principles, Georges France, external rela…
Article
The Bullish Outlook for Biosimilars
The global evolution of regulatory pathways for biosimilars has been uneven. Twenty-four countries now have biosimilar pathways or have approved follow-on biologics (4).
The EU established the firs…
Article
Challenges and Trends in Biopharma Facility Design
… carefully consider parameters such as facility design, quality, time and cost for construction, and regulatory requirements. The quality of the facility is an important factor, including ensuring th…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
The implementation of a risk-based strategy for the testing of residual impurities, meanwhile, offers the potential to significantly reduce the amount of testing needed while still meeting regulatory …
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The Importance of Partnering for Bioanalytical Studies
Bioanalyses data are also an important inclusion in regulatory filings, which drives the need for outsourcing partners who have expertise and in-depth experience in developing and conducting the appro…
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Moving PAT from Concept to Reality
Still on the learning curve
The biopharmaceutical industry and regulatory agencies have recognized the value of PAT. Although many large multinational manufacturers have adopted and implemented va…
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Biopharma Seeks Balance
Peters
A biopharma company answers to multiple masters: the patient who depends on effective drug products for health or survival; regulatory authorities that monitor quality; …
Article
FDA Framework Spurs Advanced Therapies
FDA as facilitator
The original regulatory framework for regenerative medicines, established in 2005, has not kept pace with changes that have occurred. Gottlieb is concerned that “unscrupulous ac…
Article
mAbs to Watch in 2016
Sarilumab—This IL-6-receptor inhibitor from Sanofi and Regeneron—meant to treat rheumatoid arthritis—was originally projected by some sources to gain regulatory approval in 2015, but is now expected t…
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Quality Systems Key to Lifecycle Drug Management
FDA officials have long proposed that manufacturers implementing quality-by-design (QbD) approaches and quality controls should be able to manage postapproval changes with less regulatory oversight. T…