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These include: Clarification of scope and marketing status requirements Updated reporting criteria for serious adverse events Distinction between spontaneous and solicited reports Additional examples for identifiable patient information Revised literature reporting requirements Updated lack-of-efficacy reporting criteria Inclusion of eCTD as an alternative submission platform for therapeutic products Revised submission methods for RMP-related documents Serious Adverse Event Reporting The guidance states that companies must report any serious adverse event (SAE) to HSA within 15 calendar days after first becoming aware of the event

Choose an Injection Site Intramuscular injections are typically administered in one of three locations: Upper arm (deltoid): Outer, rounded part of the upper arm, about halfway between the shoulder and elbow

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Here is the part the supplement sites skip