Attached is what is completed thus far. Please assist in answering the following. Message if you have any questions.
Q10. Under what conditions is a manufacturer allowed to change the production of an approved drug?
Q11. How does Health Canada treat an application for approval for a new biologic? How does it differ from a New Drug Submission?
Q12. What is considered a drug, according to Health Canada? Who reviews drugs for safety, efficacy, and quality?
Q13. When did the European Commission harmonize the rules relating to medical devices, and what devices did the three resulting directives cover?
Q14. In the US Food and Drug Administration (USFDA), how many Centers are there in the Office of Medical Products and Tobacco? Which Centers focus on medical devices, biologics, and drugs?
Q15. How many Offices are there in CBER? Do any of the Offices focus on medical devices or biologics?
Q16. What is the Code of Federal Regulations? Which title covers the Food and Drug Administration (FDA)?
Q17. What must each person engaged in the manufacture, processing, packaging, or holding of a drug product have? And what are these peoples responsibilities?
Q18. According to CFR21.820, what happens if a manufacturer offers a medical device for import into the United States and refuses the completion of a Food and Drug Administration inspection of the facility making the device?
Q19. To whom does CFR21.822 apply? How does someone know if CFR21.822 applies to them?
Q20. Is it possible for the FDA to grant marketing approval for a new drug product where safety has been established in animal studies alone?
Q21. When was the Pre-IND Consultation Program started? What was it designed to do?
Q22. How many divisions within the FDA are currently part of the Pre-IND Consultations Program?
Q23. Are written responses from the FDA ever deemed equivalent to a meeting?
Q24. How do you request a meeting with the FDA?
Q25. What is a type B meeting? How long does it take to schedule this type of meeting?
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