Combination Products Flashcards
Definition of Combination Products
Combination products are therapeutic, aesthetic, and diagnostic products that combine drugs, devices, and/or biological products.
Disruptive Medicine Innovation
Combining precision diagnostics and precision therapeutic/aesthetic products for unmet medical needs and next generational needs - product lifecycle management.
Future Product Strategy
Being able to construct, fabricate, regulate, and combine therapeutic and/or aesthetic biopharma products and devices through material science application with a size in the nano-range (at least one dimension) to support user centric products.
Understanding the “landscape” of the quality management system(s) within a company.
QMS Overview
Policies
Principles
Processes
Work instruction, standards, guidelines ect.
ICH Q10 is what
Pharmaceutical Quality System
What are the GMP regulations for Drugs
21 CFR 210 and 211
What are quality regulations for Device
21 CFR part 820
What quality system is followed for Combination products
21 CFR 210/211 AND 21 CFR 820
Clinical Hazards List
Identification of potential harms or hazards early in the design process.
Usability FMEA
Used to assess the risks associated with the use and reasonably foreseeable misuse of the product.
Design FMEA
Used to assess the risks associated with failure of design components impacting the ability of the system to meet the defined Design Inputs.
Process FMEA
Used to systematically identify failure modes and their corresponding effects for each step in a particular manufacturing process
Combination Product Characterization Overview
Consider starting the characterization of the combination asset as soon as possible, especially for novel products to determine the Primary Mode of Action (PMOA) to determine the clinical trial application type – Investigational Device Exemption (IDE) or Investigational New Drug (IND) application.
A Sponsor/Company will submit an IDE if the combination product has a device PMOA and an IND is submitted if the combination product has a drug or biologic PMOA.
Key terms of combination product include
Constituent part
product part
type
PMOA (Primary Mode of Action)
What is the primary mode of action (PMOA)
is the single mode of action of a combination product that provides the most important therapeutic action of the combination product
What is the most critical element in determining regulatory pathway for combination prodcuts
PMOA (Primary mode of action)
Where is the primary mode of action defined in CFR
21 CFR 3.2m
IDE Regulations
21 CFR 812
Regulations governing review boards
21 CFR 56
Informed consent regulations
21 CFR 50
IDE Product Classification
Where device component provides the primary mode of action, are regulated as Class III devices that require the submission and approval of a premarket approval (PMA) application prior to commercial marketing in the United States.
To meet the standard for approval, the PMA application must contain (or include by reference) valid scientific evidence to provide a reasonable assurance of safety and effectiveness of the product when used in accordance with its labeled indication (21 U.S.C. 360c(a)(1)(C), 360c(a)(2)-(3)). Such evidence will usually consist of nonclinical, animal, and human clinical testing.
IDE Requirements:
An IDE application is required, a sponsor must not begin a clinical trial in humans in the United States until FDA has approved the application (21 CFR 812.20(a)(2), 812.42). Sponsors of such studies must comply with the following:
IDE Product Classification
Pre-submission interactions for areas IDE application can be broad-based, or can focus on areas, such as engineering testing, CMC testing, or clinical protocols. Sponsors should clearly identify questions or items they would like to have addressed as part of the pre-submission interaction.
