Question: We import serum samples drawn from patients involved in a human clinical trial. These are potentially infectious with severe acute respiratory coronavirus 2, influenza A viruses & influenza B viruses.Our Clin Opps team has obtained a CDC Permit. They told me that these samples are not subject to FDA oversight.I went into the FDA Product […]
Question: We’re importing a AMR MD autonomous mobile robot into the United States and per the HTS classification 8537.10.9170 this product flags for FDA (FD1). The AMR MD-650 is an industrial autonomous mobile robot designed solely for automated material transport within factories and warehouse environments. It includes drive systems, sensors (including LiDAR), control electronics, and […]
Question: SCENARIO – I was informed by the supplier that they are facing an issue with serialization for our commercial lot of finished product vaccines. The supplier is requesting to pull a certain number of doses from the clinical orders so that they can complete the serialization of the commercial lot. The commercial batch serialization […]
Question: Can anyone explain why it is important for trade compliance and logistics to understand the difference between the different stages of vaccine development – Pre-Clinical, Phase 1, Phase 2, Phase 3 and FDA Approved? Answer 1: It is important for multiple reasons. Valuation is an important one.If a product is FDA approved, it will […]
Question: We are importing fully released, CBER-approved commercial lots to use in Clinical Trials. Are approved vaccines used in clinical trials considered to be investigation new drugs? Do we need to meet the labeling requirements of 312.6 (“Caution: For clinical trial use only”) even though this is a fully released, CBER-approved commercial lots because the […]
Question: I had submitted a question regarding the FDA Product Code PHN and asked for examples of what this meant. I received a helpful answer – “Diluents, solvents used in manufacturing, flavoring used in medications, preservatives.”I have a follow up question(s): what if the buffer is being imported for lab testing purposes. The buffer does […]
Question: Can anyone tell me the definition of PHN? What is an example of a PHN? Answer 1: Diluents, solvents used in manufacturing, flavoring used in medications, preservatives.
Question: My company occasionally imports non-medical equipment that flags for FDA (laser printers, touch screens, etc). These are not typically purchased directly from the manufacturer, but as part of a bigger package. Is the “manufacturer” information that is reported to Customs the name-brand manufacturer? Or is it expected to be the small, possibly sub-contracted factory […]
Question: We are importing a commercial vaccine to and sending it to another company where it will be used as a comparator in a clinical trial that other company is running. Do we need to import the comparator and declare it to the FDA with the intended as clinical trial and import it under the […]
Question: Three-part question Can anyone explain the difference between FDA Hold and FDA Detained? Is there an FDA Glossary available online somewhere? Is an FDA approved drug or vaccine imported for use as a comparator in a clinical trial sponsored by another party also considered an investigational drug and should it be imported under the […]
Question: I’ve searched the FDA regulations and resources and cannot locate a definition for “further processing” or “further processed”. Looking for a clear definition and also example listing of what meets (i.e. sterilization, manufacture, package/label, etc.). Was hoping someone might be able to provide resource links or details. Thank you! Answer 1: According to Regulatory […]
Question: We import finished pharmaceutical products. Sometimes the API supplier changes for the drug we are importing from lot to lot. Thus, it is possible that there could be 2 lines on the entry for the same product, that have different API suppliers. Our current broker links a single API supplier to our part number […]
