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Faster development processes have led to some difficulties in completing quality and manufacturing development and data requirements, the meeting report said. Read More
The EMA and FDA have released a report on their workshop to discuss possible solutions to quality and manufacturing challenges drugmakers face when developing medicines under early access programs. Read More
The guidance focuses on identifying critical to quality factors and risk mitigation and emphasizes that patients should be consulted early in the design process. Read More
The FDA is seeking its own set of comments on ICH E8(R1) draft guidance issued by the International Council for Harmonisation earlier this year on designing quality clinical trials. Read More
In response to rising drug pricing, HHS and FDA have announced a plan to create two potential pathways to import drugs originally intended for foreign markets. Read More
The updated guidance explains the agency’s thinking and approach towards analytical methods to determine similarity to reference products, as well as broader quality-related issues for biosimilars. Read More