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FDA Issues Guidance On Compounding Animal Drugs From Bulk Drug Substances - Life Sciences, Biotechnology & Nanotechnology - Vimarsana News

FDA Issues Guidance On Compounding Animal Drugs From Bulk Drug Substances - Life Sciences, Biotechnology & Nanotechnology

On April 13, 2022, the FDA issued Guidance for Industry #256 about the enforcement policy regarding the compounding of animal drugs from bulk drug substances by or under the...

Source: mondaq.com
FDA Final Guidance On Initiating Voluntary Recalls: Be - Vimarsana News

FDA Final Guidance On Initiating Voluntary Recalls: Be

On March 4, 2022, FDA issued a final guidance to industry and FDA staff regarding the initiation of voluntary recalls under 21 CFR part 7...

Source: mondaq.com
District Court Of Delaware Rules For Generic Pharma's Use Of Skinny Label, But Permits Induced Infringement Suit To Proceed Against Insurer - Food, Drugs, Healthcare, Life Sciences - Vimarsana News

District Court Of Delaware Rules For Generic Pharma's Use Of Skinny Label, But Permits Induced Infringement Suit To Proceed Against Insurer - Food, Drugs, Healthcare, Life Sciences

Hikma received FDA's approval to sell a generic version for the SH indication only and carved out the patented use.

Source: mondaq.com