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What should the overall system be tested to ensure proper performance to?
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design specifications
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What is the manufacturing process for 392 Prototype 2 comparable to?
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that for Prototype 1
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What is the level of concern related to risks associated with?
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software failure
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What is the purpose of the focused ultrasound stimulator system?
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aesthetic use under simulated use conditions
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What should studies permit an assessment of?
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the probability of an inadvertent deposition of energy into distal and/or surrounding non-target tissue
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What should preclinical animal studies follow?
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modern practices of humane care and use
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What will the FDA rely on instead of requiring clinical studies?
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well-designed bench and/or animal testing
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What is the use of a dissimilar ultrasound stimulator system for aesthetic use?
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indications for use dissimilar from a legally marketed system of the same type
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What is a significant portion of the target popul?
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aesthetic
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What is the name of the book that Burch wrote about the principles of humane Experimental Technique?
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The Principles of Humane Experimental Technique
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What is the name of the regulation that requires a clinical study to demonstrate substantial equivalence?
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Investigational Device Exemptions (IDE)
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What may lead to differences in the injection 399 angle?
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changing the 397 dimensions and materials of the rear and front shell subassemblies’ internal 398 components
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What must sponsors of trials comply with in addition to having an FDA-approved IDE?
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regulations governing institutional review boards
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What is the name of the FDA-recognized standard?
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EMC
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What does IEC 60601-1-2 stand for?
| null |
What does IEC 60601-1-2 stand for?
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Medical Electrical Equipment – Part 1: General Requirements for Safety; Electromagnetic compatibility – Requirements and Tests.
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What must labeling satisfy the requirements of?
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21 CFR 807.87(e)
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What must include, however, adequate information for practitioner use of the device?
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Labeling
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What do you recommend users with open wounds or lesions not to use?
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the device
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What must be included in the user manual?
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storage conditions
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What should be included to ensure complete handpiece skin contact and to not expose the eyes to ultrasound radiation?
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a warning
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What should be identified for any laboratory tests or other evaluations?
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laboratory tests or other evaluations
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What should be helpful in following the patient’s response or identify adverse reactions and, if appropriate, specify the frequency of such tests or evaluations before, during and after use of the device.?
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What did the applicant not gather for the TBM product?
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new clinical data
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What should all animal studies be designed based on?
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modern practices described in the following references
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What is the name of the act that expanded the use of animals in research?
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Public Law 99-158 “Animals in Research”
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What is the name of the guide for the care and use of Laboratory Animals?
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National Research Council
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What is the phone number for Patricia Y. Love, MD, Office of Combination Products?
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301-427-1934
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What is the name of the Office of Combination Products?
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OCP
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Where can you submit electronic comments for the FDA?
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http://www.fda.gov/dockets/ecomments
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What is the definition of combination products?
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3 A. Definition
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What is the name of the guidance that represents the Food and Drug Administration?
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Guidance for Industry and FDA Staff
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What does the approach satisfies the requirements of?
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applicable statutes 8 and regulations
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What is the purpose of this document?
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provide a context for initial discussions on the type of scientific and technical information that 16 may be necessary for investigational or marketing applications for these combination products
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What was the TBM device tested in accordance with?
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relevant 406 standards
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What is CDRH?
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Center for Devices and Radiological Health
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What is the Center for Devices and Radiological Health?
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Center for Biologics Evaluat
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What is the Office of Combination Products called?
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Office of Combination Products
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What can be used in combination to potentially 37 enhance the safety and effectiveness of either product used alone?
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Drug and biologic products
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What provides a new route of insulin delivery 40 that may decrease the need for insulin injections.?
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What does FDA recognize that combination product development may raise a number of?
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Critical Path4 49 challenges
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What may need to be developed for manufacturing, evaluation 54 of preclinical safety in targeted areas of the body, or clinical trial design to establish sa?
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New methodologies
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What does FDA believe is important to address?
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scientific and tech
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What are the issues raised by innovative combination products?
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safety, effectiveness, and quality of the combination product
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What is a summary of the workshop available at?
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http://www.fda.gov/oc/combination/workshop070803.html
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What is the name of the example of the drug that could affect the delivery?
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Injection time
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What is a drug, device, and a biological product?
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68 drug, device, and a biological product
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What is the intended use of a drug, device, or biological product?
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intended for use only with an approved 80 individually specified drug, device, or biological product
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What is a constituent part of a combination product for purposes of this guidance?
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an article in a 92 combinat
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What is the public health service act?
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42 U.S.C. 252 (i), Public Health Service Act
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What is the OCP?
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Office of Combination Products
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What does OCP ensure timely and 107 effective premarket review by overseeing the timeliness of and coordinating reviews involving 108 more than one agency center?
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What is the PMOA of a device-biologic combinat?
|
the primary mode of action of a combination 115 product that provides the most important therapeutic action of the combination product
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What is the final 119 regulation also included?
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assignment algorithm
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What is the lead center responsible for?
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the review and 124 regulation of the combination product
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What is the goal of the SOP?
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ensure timely and 132 effective intercenter communication on combination products
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What did the applicant identify that can be applied to the modified TBM 426 autoinjector?
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the dose accuracy, delivery time, injection 429 depth, injection angle
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What is the FDA's recommendation for developers to contact for assistance in determining the assignment of a lead center?
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OCP
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What is the suffix for most combination products?
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a single marketing application
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What may determine that two marketing applications are necessary?
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FDA
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What does FDA encourage applicants who are uncertain as to whether a single or multiple marketing applications should be submitted for a combination product to discuss?
|
the answer: FDA encourages applicants who are uncertain as to whether a single or multiple marketing applications should be submitted for a combination product to discuss the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer: the answer:
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What is the postmarket regulations called?
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adverse event reporting
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What does combination product development typically focus on?
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scientific and technical issues raised by the particular product being developed
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What is the breadth, innovation and 155 complexity of combination products?
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there is no single developmental paradigm appropriate for 156 all combination products
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What is the guidance for preclinical evaluation of drugs/biologics different from?
|
161
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What does FDA recommend that 165 developers consider?
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the scientific and technical issues raised by the combination product and its 166 constituents
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What is important for a drug eluting stent?
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mechanical attributes of the polymer 174 coating system that contains the drug substance
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What has the applicant determined that the PK studies conducted using Prototype 1 of the autoinjector 432 can be leveraged?
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the applicant 431
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What is the purpose of the guidance document?
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to deliver a drug/biologic to a new area of the body
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What is the name of the new method that the OCP uses to determine the effect of localized/targeted delivery?
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Nonbinding Recommendations 182
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What should combination product developers consider when developing information to demonstrate the safety and effectiveness of a combination product and its constituent parts?
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general principles
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What may lead to a more targeted and efficient development pathway for 197 the co?
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Consideration of these issues in the context of 196 existing guidance documents
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What is a good starting point for considering the appropriate data to establish safety and 204 effectiveness for its use in a combination product?
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Prior FDA approval and/or clearance of a particular constituent part
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What is needed to address the scientific and technical issues raised by the 211 new use of the constituent in the combin?
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additional 210 data and information
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What is the cid:131) Is the indication for a given constituent approved?
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Is the indication for a given constituent
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What is the intended target population of the combination product?
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221
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What is the cid:131) Are the device and drug constituents chemically, physically, or otherwise combined into 229 a single entity?
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229
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What is a drug constituent that is a new molecular entity?
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a drug constituent
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What is the applicant determined to be the same?
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the applicant has determined that the 443 nonclinical, toxicity, and safety and effectiveness data gathered in the e Answer: the applicant has determined that the 443 nonclinical, toxicity, and safety and effectiveness data gathered in the e.
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What is some safety and effectiveness testing of the device alone 249 necessary before or along with the studies to establish the safety and effectiveness of the 250 combination product as a whole?
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the 250 combination product
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What would a combination product 253 incorporate?
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an indwelling, intravenous drug delivery catheter
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What may be necessary to establish the suitability of the device design to the new environment in which it 257 will be used?
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New engineering or functional testing
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What could affect safety?
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Presence of inactive breakdown products or manufacturing residues from device manufacture
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What is a drug constituent used together with?
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an energy emitting device
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What is the FDA encouraged to seek early discussions with when exploring the application of st?
|
developers
|
What is the first step in determining the safety and effectiveness of a new molecular entity when used in a combination product?
|
consideration of the 292 NME alone
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What is the information needed for combination of the NME and the device 294 constituent?
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NME
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What are the studies submitted in?
|
the marketing application for the 300 product
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What is an example of a new preclinical or clinical safety information or new clinical studies?
|
307 product
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What can be bridged to the Prototype 2 autoinjector presentation and leveraged?
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Prototype 1 autoinjector presentation
|
What is the name of the Guidance to Industry: Format and Content of Non-clinical Pharmacology/Toxicology Section of an Application?
| null |
What should the marketing application 315 316 contain?
|
appropriate data
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What is the extent that the combination product permits local or systemic drug exposure 324 that is greater than that occurring with approved dosing regimens?
|
greater
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What may be appropriate to evaluate the 326 local/regional toxicity of a drug/device combination product administered directly to targeted tissue?
|
New studies
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What might these studies be used to determine?
|
drug release kinetics
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What is the toxicity profile of the combination product?
|
NOAEL
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What is the name of the new route of administration of 348?
|
local toxicity
|
What is the ICH E1A?
|
The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
|
What is the name of the IDE?
|
Investigational Device Exemption
|
What is an alternative for exploring candidate products during research and development?
|
Exploratory IND Studies
|
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