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Sponsors submitting NDA and BLA content for bioresearch monitoring inspections should list all relevant clinical sites and entities responsible for clinical study-related activities, according to new draft guidance from the FDA on standardized formatting for BIMO inspection submissions. Read More
FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes final, according to some drug developers and patient advocacy groups. Read More
Biosimilars reduce individual patient’s out-of-pocket medical expenses and lower the financial burden on insurance payers and national health agencies, according to Celltrion CEO Woosung Kee. Read More
PhRMA, Merck and Illumina offered feedback on the FDA’s draft guidance on the development of treatments that target diseases caused by molecular alterations, requesting the agency provide more details. Read More
The FDA revised its Manual of Policies and Procedures document pertaining to issuing complete and partial clinical holds, including a reorganized background section that consolidates descriptions of IND clinical hold procedures, CFR citations and timelines for agency responses to sponsors. The new version also narrows its focus by omitting references to general IND review procedures included in the previous version that took effect in May 1998. Read More
A federal judge overturned a $2.5 billion patent infringement verdict, the largest ever in a U.S. patent case, against Gilead Sciences in a dispute with Merck. Read More
Biocom and Gilead Sciences asked the FDA for clarification on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups requested more data on the success of the program. Read More