8 questions found for FDA Law

I'm a manufacturer in Panama planning to export a dietary supplement to the United States. What FDA requirements would govern facility registration, good manufacturing practices, labeling, and any premarket notification...

We are a Chinese food manufacturer planning to ship products to the United States. We need clarity on FDA registration, facility compliance, labeling, and ongoing reporting obligations. Will we need...

I'm developing a new medicinal product and want to market it in Singapore. What regulatory pathway is required (clinical data, GMP compliance, and HSA registration), who evaluates the dossier, and...

I'm planning to bring a new medical device to the Saudi market. I'm unsure which documents SFDA requires, whether clinical data is needed, and the typical processing time. Do I...

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)...