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Physicians › Final Guidance

Smart & Biggar

Special Access Program and Emergency Drug Release Program amendments in force

Smart & Biggar on

On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

King & Spalding

FDA Issues New Form FDA 3926 and Final Guidance for Its Use, a New Approach for Physicians to Request FDA Approval for Expanded...

King & Spalding on

Agency Also Finalizes Additional Guidance Regarding Expanded Access (“Compassionate Use”) - On June 2, 2016, the Food and Drug Administration (FDA) issued final guidance “Individual Patient Expanded Access...more

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