Pharmaceutical regulatory Affairs

  Clinical trial T he corner stone of all medical advancements is clinical research, which includes clinical trials. Clinical trials investigate novel approaches to illness detection, prevention, and treatment. Clinical trials may investigate: Novel medications or novel drug combinations.    Research on novel diagnostic procedures and therapeutic approaches that evaluate their impact on human health outcomes is known as clinical trials.   In order to evaluate medications, stem cells, and other biological products, surgical techniques, radiological techniques, gadgets, behavioral therapies, and preventive care, people volunteer to participate in clinical trials.   Clinical studies require approval before they can begin and must be well-organized, evaluated, and finished. Clinical trials are open to participants of all ages, including minors.   Clinical trials for medical conditions include four stages...

        Drug Master Files A Drug Master File (DMF) is a submission to the FDA that may be used to provide confidential detailed information about facilities, human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. An Export Application, a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or an Investigational New Drug Application (IND) may be supported by the data in the DMF. modifications and additions to any of these.” DMFs :   are often made so that material can be referenced by parties other than the DMF holder without revealing the file's contents to them.   do not substitute for other applications, including BLAs, ANDAs, INDs, or NDAs. are neither specifically accepted or rejected by the FDA Types of DMFs Status of DMFs A”- Active; this means that the DMF was found acceptable for filing, administratively, and has not been closed. “...