and establish strong compliance programs to ensure that the company, as a clinical trial sponsor, meets all quality system and other FDA requirements.
Diagnostic features: Infiltrating cells include lymphocytes, plasma cells, macrophages, and occasionally multinucleated giant cells
When to seek medical advice: Persistent or worsening injection site reactions (increasing redness, warmth, or discharge suggesting infection) Severe or persistent headaches Chest pain or palpitations Unexplained muscle weakness or cramps New or worsening neurological symptoms despite treatment Unexpected bleeding or bruising For non-emergency concerns, contact your GP or NHS 111
Sandoval H, Thiagarajan P, Dasgupta SK, Schumacher A, Prchal JT, Chen M, Wang J