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Take the time to browse the selection of products and talk to the sales representatives to see what information you can get about where the hemp extracts are sourced from and how they are extracted. If the selected hemp manufacturer holds a Drug Master File (DMF), the sponsor must obtain a Letter of Authorization (LOA) to reference CMC and BRM information. Step 4: If the selected BRM or drug substance manufacturer holds a Drug Master File (DMF), the sponsor must obtain a Letter of Authorization (LOA) to reference CMC and BRM information. 2. Providing information on the specific requirements needed to develop a human drug that is derived from a plant such as cannabis. 3. Providing specific support for investigators interested in conducting clinical research using cannabis and its constituents as a part of the IND or investigational new animal drug (INAD) process through meetings and regular interactions throughout the drug development process. In keeping with this strategy, the firm recently opened a second corporate headquarters in Dallas, Texas, to support its continued growth in Texas and expansion into the Southeast. If the research is intended to support the approval of an animal drug product, an INAD file should be established with CVM.
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