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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The FDA’s updated draft guidance on comparative analytical assessments for biosimilars is useful and usable for developers of copycat medicines, drugmakers and trade groups expressed in public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
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended five new medicines for approval and eight treatments for extensions of indication at its July meeting. Read More
“[FDA] could have opened the door to the domestic production of generic insulin, resulting in unprecedented competition in the insulin market, making it more accessible and affordable,” he said. Read More
The resolution is in response to the “CRISPR babies” scandal that erupted following the announcement by researcher He Jiankui who claimed to have used the CRISPR-Cas9 technique to disable the CCR5 gene that allows HIV to infect humans. Read More