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FDA Approves NIH-Funded Genetic Database, Issues Draft Guidance on NASH

The FDA issued draft guidance for biopharma companies on developing therapies for NASH with liver fibrosis.

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FDA Suggests Use of Placebo is Necessary Only in Certain Types of Oncology Trials

In a new draft guidance, the U.S. FDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary.

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FDA Issues New Draft Guidance to Promote Development of Medications to Treat Opioid Use Disorder

The U.S. Food and Drug Administration issued a new draft guidance for the development of novel medicines aimed at the treatment of opioid use disorder.

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FDA Withdraws Draft Guidance on Biosimilar Development

The U.S. Food and Drug Administration withdrew the regulatory agency’s draft guidance on statistical methods to evaluate the analytical similarity between branded drugs and biosimilars.

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U.S. FDA looks to pave way for earlier-stage Alzheimer’s drugs

U.S. regulators proposed lowering the bar for clinical trial success for experimental Alzheimer’s drugs.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on steps to promote development of generic versions of opioids formulated to deter abuse

“As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. …”

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FDA announces comprehensive regenerative medicine policy framework

The U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.

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