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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