4 questions found for FDA Law

I'm a Bulgarian food producer planning to export to the United States. What FDA registration and labeling requirements, and pre-market considerations, do I need to address before first shipments? Is...

We manufacture dietary supplements in Hong Kong and ship to the United States. We’re unsure whether FDA labeling rules and facility registration apply to our products and what steps we...

I'm preparing to register a new medicine with the Kenyan regulator, but they say the submission lacks required data and may be rejected. What rights do I have to appeal...

I'm developing a nutraceutical and want to know if it requires HSA registration or product notification before sale in Singapore. How do labeling claims affect regulatory categorization (drug vs. supplement)...