BTRA 641 UMGC Product Life Cycle Discussion
Description
- What are the three general problem areas with labeling FDA has encountered?
- What are the exemptions from labeling for IVDs?
- How long does an applicant/sponsor have to report an adverse drug experience? What are the procedures for an applicant/sponsor after submitting an Alert Report?
- Approximately how many generic types of medical devices of FDA recognize? How many medical specialties are these devices grouped into?
- What is/are the difference(s) between premarket approval and 510(k)?
- What are the criteria for determining if a manufacturer of a medical device must conduct postmarket surveillance?
- What type of post-market studies can FDA require?
- When are annual reports required for an ANDA and an NDA?
- When are annual reports required for a BLA?
- If a company is marketing a device and it wants to use the same device for something else, what kind of application must the company file?
- What information from medical device reports (MDR) can FDA disclose to the public?
- What responsibility do manufacturers have with regard to keeping copies/records/files of MDRs?
- Does a manufacturer need to provide FDA with a postmarket surveillance plan? If so, does it need approval before it can be enacted?
- When is it best to file an ANDA instead of an NDA?
- According to the FDA, what are the requirements for submitting a BLA?
- Does an IND have to be filed before a BLA? If so then why?
- What types of records are manufacturers/sponsors/investigators required to keep during the postmarket surveillance period?
- Is postmarket surveillance ever required for a class I medical device? What about class II?
- What law does the FDA use to take legal action against regulated products? And how does it define a label?
- Generally, what is the approval process for vaccines?
- According to the FDA, what are the goals of the NDA?
- Is advertising considered part of labeling?
- What are the requirements for labeling the immediate container of IVDs?
- Is there a specific language labeling should be written in?
- What are the requirements for the labeling of inserts and outer packaging? Please add reference list in APA style
