Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
|---|---|
What is the name of the device that is not used in intra-operative procedures? | CADe devices |
What is the injection time of the TBM autoinjector? | 456 unchanged |
What is the FDA's recommendation for drug developers? | techniques to measure drug levels in areas not typically accessible |
What would such studies evaluate how users operate the system in realistic, stressful conditions? | how users operate the system |
What are important considerations during the development of a combination product? | Manufacturing considerations 388 389 Manufacturing, scale-up, and quality management17 |
What may be altered or destroyed by terminal sterilization tech? | Certain drug or biological product constituent parts |
What may affect the safety or effectiveness of the combination product as a 404 whole? | any potential 402 change in the manufacturing process for the drug, biologic, or device constituents or for the 403 combination product |
What may vary with the time and methods used for cellular incubation before application to the device 408 constituent? | performance characteristics 407 |
What is the name of the study that may be necessary to assess changes in the constituent parts and for the combination product as a whole? | testing specifications |
What does FDA encourage manufacturers to establish with manufacturers of constituent parts to maintain sufficient awareness of? | manufacturing changes in constituent parts |
What is the potential impact of a manufacturing change evaluated in a manner appropriate for the stage of combination product development? | 422 |
What may developers wish to provide in one marketing application? | all necessary information |
What does the applicant determine is not needed to be bridged? | existing information that may be 462 leveraged |
What is the name of the letter that would grant FDA permission to consider the referenced material in its review of the current application? | authorized cross reference from the owner of the 435 referenced material |
What is not a substitute for a master file? | A master file |
What is considered in the context of a particular investigational 451 or marketing application? | 450 information in a master file |
What is the name of the document that contains the information on drug master files? | 21 CFR 458 314.420 |
What does early dialogue allow developers to obtain? | initial 468 feedback on the kinds of preclinical and clinical testing that may be necessary |
What is the purpose of the pre- 477 investigational meetings? | discussing innova |
What is the name of the organization that should be contacted to schedule meetings in accordance with the procedures and 485 milestones appl? | The lead center |
What is the OCP available for? | as a resource to developers and review staff throughout the lifecycle 494 |
What is the CDRH Guidance web page accessible at? | 503 http://www.fda.gov/cdrh/guidance.html |
What is the FDA's guidance for Industry on how to write a Request for Designation? | Guidance for Industry and CDRH Staff |
What is the purpose of the side-by-side comparison of the user interface for the combination product using Prototype 1? | 469 comparison |
What is the OCP? | Office of Combination Products |
What is the address of the office that handles the design of combination products? | 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 |
What is a Request for Designation? | Request for Designation |
What is the name of the FDA’s electronic su? | OCP |
What is the name of the section that provides contact information for sponsors? | 3.7(c)(1) 8 |
What is the purpose of Section 3.7(c)(2)(vi)? | 8. Proposed Use or Indications |
What is the limit on the amount of pages a request for designation can be submitted to? | 15 pages |
What can you use if the approach satisfies the requirements of the applicable statutes and regulations? | an alternative approach |
What does OCP stand for? | Office of Combination Products |
What is the final rule defining the primary mode of action of a combination product called? | PMOA Final Rule |
What is Combination Product A indicated for? | the prevention and relief of 481 bronchospasm |
What is the FD&C Act's Section 563? | the FD&C Act |
What is the term that does not include combination products as defined in 21 CFR 3.2(e)? | non-combination product |
What is the purpose of the term “device”? | the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals |
What is the purpose of a component, part, or accessory? | (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, |
What is the term biological product used for? | a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein |
What is a combination product comprised of? | a combination of a drug and a device; a biological product and a device; a drug and a biological product |
What would need to be changed upon approval of the proposed product? | labeling of the approved product |
What is an RFD also referred to as an applicant’s letter of request? | an applicant’s letter of request |
What is a written submission to OCP? | RFDs |
What defines the term agency center as a center or alternative organizational component of the Food and Drug Administration? | Section 503(g) of the FD&C Act |
What is the purpose of Combination Product B? | an indication of prevention and relief of 485 bronchospasm in patients 4 years of age and older with reversible obstructive airway disease |
What is a potential stay of the review clock if the classification or assignment of the product under Answer: Answer: unclear or in dispute? | null |
What is the definition of a product that has different configurations, ingredients, and/or proposed? | product families |
What do we encourage you to contact before submitting my RFD? | OCP |
What can you request prior to submitting an RFD? | a meeting |
What is the determination pertains only to the product described in the designation letter? | the product |
What is the RFD process outlined in? | 21 CFR Part 3 |
What will OCP review within 5 business days of its receipt of an RFD? | the submission for completeness and determine whether the RFD contains the required information |
What is the date by which FDA plans to respond to the RFD? | acknowledgement letter |
What is the ssignment section of the FD&C Act? | 21 CFR 3.8(b) |
What is the maximum amount of information that cannot be included in your original RFD? | five pages |
What is the purpose of the combination products 489 products? | to rapidly reverse bronchospasm |
What is the name of the agency that can be reached by contacting OCP? | OCP |
What is the name of the section that requires you to include the following information in an RFD? | Section Answer: Section: What information must I include in my RFD |
What is the name of the sponsor? | company name and address |
What is the name of the sponsor of the product? | sponsors |
What is the name of the sponsor’s identification of the single mode of action that provides the most important therapeutic action of the product? | sponsor |
What format should I follow for my RFD? | format and organization desc |
What is the standard typeface for an RFD? | Times New Roman |
What should the envelope be clearly marked as in order for the RFD to be sent to the correct location? | null |
What is the common electronic format for RFDs? | Portable Document Format (PDF) |
What information does FDA recommend that sponsors provide in RFD submissions? | Sponsors must provide the information required in 21 CFR 3.7 |
What must you include if you have chosen a proprietary name for your product? | company establishment registration number (if applicable), and telephone number |
What is the tric age 495 group? | 495 |
What must you include in your RFD? | description of the Product |
What does Section 3.7(c)(2)(iv) require? | prior Approvals and Agreements |
What section of the FD&C Act does a device exempt from premarket notification requirements? | 510(k) |
What is the name of the section of the FD&C Act that requires a new drug application to be submitted to the FDA? | 505 |
What must you include in your submission according to 21 CFR 3.7(c)(2)(v)? | chemical, physical and/or biological composition |
What is important for the appropriate classification and jurisdictional assignment of your product? | PMOA of a combination product |
What section of your RFD is critical? | proposed use or indications |
What is the mode of action of a drug, device, biological product, or combination product? | PMOA |
What is a mode of action? | the means by which a product achieves an intended therapeutic effect or action |
What is an icle? | biological product, device, or drug |
What is the applicant's decision about the user interface? | the uses, and environments of use of the products is unchanged |
What is the mode of action expected to make the greatest contribut? | mode of action |
What must you identify if your product is a combination product? | the mode of action that you believe to be the single mode of action that provid |
What must you include in your argument? | the basis for why you think that action is the most important |
What should you provide if you choose to cite “in press” literature? | copies of the referenced material |
What should be included in the 15 page RFD? | information or data which is only available in your company’s internal research report(s) |
What is the basis for your conclusion? | Which mode of action makes the greatest contribution |
What is the mode of action expected to make the greatest contribution to the overall intended therapeutic effects of the product? | mode of action |
What is the PMOA of a combination product complicated for? | products where the product has two completely distinct therapeutic effects achieved by completely different modes of action, neither of which is subordinate to the other |
What is the first step of the assignment algorithm? | if there are other combination products that present similar questions of safety and effectiveness with regard to the combination product as a whole, the Agency will assign the combination product to the Agency component that regulates those other combination products. |
What is the second step in the RFD? | under which we would assign the combination product to the Ag Answer: the Ag Answer: the Ag Answer: the combination product |
What did ysis create between Combination Products A and B? | a bridge 512 for adult user interface information |
What are the factors listed below intended to further illustrate? | the kinds of issues that may be relevant when determining whether a new combination product presents safety and effectiveness issues similar to those presented by a previous combination product |
What allows the Agency to take into account technological developments, evolving scientific understanding, and specific factual information concerning the particular product? | case-by-case analysis |
What is a drug constituent part a new molecular entity or new formulation? | a drug constituent part |
What is another of the constituent parts that presents more significant safety and effectiveness issues relating to the risks it poses, its effectiveness, or its novelty? | presents more significant safety and effectiveness issues |
What must you do if you cannot determine with reasonable certainty the most important therapeutic action of your combination product? | recommend an assignment for your product based on the assignment algorithm |
What should you identify any other combination products that you are aware of that you believe FDA should consider in determining the assignment of your product? | any such other combination products that you are aware of that you believe FDA should consider in determining the assignment of your product |
What should you identify if you do not believe your product is similar to another combination product? | ontact lens |
What should the Agency explain in their opinion to the Center that has the most expertise related to those questions? | which Center has the most expertise |
What are the most significant safety and effectiveness questions raised by the vision-correcting contact lens? | the characterization, manufacturing, and clinical performance |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.