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The agency wants to see risk information on serious eye disorders that can result from unintended exposure to the drug and the potential for severe local skin reactions. Read More
CBER released an updated list of guidances it plans to publish this year, including draft recommendations on the following gene therapy topics: Read More
Regulators might be willing to approve heart failure drugs that make patients feel better even if they don’t keep patients out of the hospital — or even alive, the FDA said in a new draft guidance document issued Thursday. Read More
Woodcock highlighted a proposal in the administration’s budget request that would impact the 180-day exclusivity available to first filers of medications. Read More
The agency recommends that companies “consider providing information on whether their drug has any characteristics that would mitigate the risks of overdose, abuse or the development of addiction.” Read More