GCP/ICH Obligations: 12 Tips for Site Teams
ICH E6(R3) — effective July 2025 under EMA and published by FDA in September 2025 — is the most significant update to Good Clinical Practice in nearly three decades. While the guideline introduces a risk-proportionate, Quality by Design framework,
Food and Drug Law: 10 Prohibited Actions Tips
Section 301 of the FDCA (21 U.S.C. Section 331) lists the prohibited acts — the specific conduct that triggers FDA enforcement authority. The list is long, but the core prohibited acts fall into recognizable categories: adulteration, misbranding,
First Aid for Medical Emergencies: 10 Workplace Tips
Medical emergencies in the workplace — cardiac events, strokes, severe bleeding, seizures, and heat stroke — are time-critical by definition. The outcome for a worker in cardiac arrest is shaped almost entirely by what happens in the first four mi
Bone, Joint and Muscle Injuries: 10 First Aid Tips
A splint that only immobilizes the fracture site itself is inadequate. Movement at either adjacent joint can cause movement at the fracture site. The rule is: immobilize the joint above and the joint below the injury. Two-joint immobilization: exa
Workplace First Aid Introduction: 10 Setup Tips
Most workplaces have a first aid kit somewhere. Fewer have a first aid program that would hold up to an OSHA inspection or, more importantly, to an actual emergency. OSHA's framework under 29 CFR 1910.151 (general industry) and 1926.50 (constructi