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The FDA is seeking its own set of comments on ICH E8(R1) draft guidance issued by the International Council for Harmonisation earlier this year on designing quality clinical trials.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The FDA’s updated draft guidance on comparative analytical assessments for biosimilars is useful and usable for developers of copycat medicines, drugmakers and trade groups expressed in public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
PhRMA, as expected, expressed opposition towards the sweeping bipartisan bill, calling it “the wrong approach” for tackling the nation’s high drug costs. Read More
Drugmakers have been given more clarity on the FDA’s definition of rare pediatric disease and the process for its priority review voucher program in agency draft revised guidance issued Monday. Read More
Some Type II DMF submissions may receive a waiver for noncommercial applications, such as ones from an academic institution, government or non-profit research group. Read More