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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The FDA is seeking its own set of comments on ICH E8(R1) draft guidance issued by the International Council for Harmonisation earlier this year on designing quality clinical trials.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
Heparin, an intravenous anticoagulant, is an essential product in hospitals and is the only anticoagulant used in the U.S. for kidney dialysis and open heart surgeries, the committee said. Read More
The FDA’s updated draft guidance on comparative analytical assessments for biosimilars is useful and usable for developers of copycat medicines, drugmakers and trade groups expressed in public comments. Read More