What is combination product.
When any of the drug product or biological products or diagnostic products kits or medical devices are combined together to provide increase efficacy and performance of the products or to enhance the efficacy of the therapy.
As the combination products involve different types of combinations say biological product combined with a medical device, then these products are evaluated and approved by different centers of US FDA. Each drug product or the medical device in combination is required to go through different evaluation paths. Are required to comply with the different regulation with respect to preclinical testing, quality control and manufacturing.
Which are combination products ( definition of combinition Combination products are defines in Under 21 CFR 3.2 (e) ).
(1) A product is called as combination product if it comprises of two or more components which example 1) Medical device/ and a drug product 2) biological product and drug product or medical devices and aid and biological product .
When these a single product is produced by mixing chemically or physically combined together to perform as a single product as described above to facilitate increase the efficacy of therapy or the products it self.
(2)When two or more of following products are packed in a single package as a single unit they are considered as a combination products.
1) Biological product and drug product.
2) Drug product and medical device products
3) Medical device and biological product,
Investigational Combination Drug product.
A) Investigational + Previously approved product.
An investigational drug or medical device will be classified as combination product when its investigational plan and proposed labeling requires its use only with a previously approved drug product or medical devices or a biological product for an indication or for a therapeutic action , after approval of this product it is required that the products labeling is changed accordingly.
B) Investigational + Investigational Product.
Investigational new drugs combined with other investigational drug:
When an investigational new drug investigational drug, device, or biological is packed separately but it is required or intended use in combination with other investigational investigational drug, device, or biological product to gain a desired therapeutic effect.
Examples of combination products are as follows:
1.A drug product combined with monoclonal antibodies to enhance therapeutic efficacy of monoclonal antibodies or the drug product.
2.A medical device coated with a drug or a biological:
Steroid coated tip pacing device , drug eluting stents , Antimicrobial coated catheter antimicrobial coating.
Cellular component with skin substitute , prefilled syringes of a drug or insulin , surgical implants coated with drug like growth factor .
Transdermal patches and metered dose inhalers
Photosensitizing drug and activating laser/light source
Iontophoretic drug delivery patch.
Combination products and their- Current Good Manufacturing Practices Guidelines (c gmp guidelines):
Section 501 of Act states that a drug or medical device can be deemed as adulterated if manufacturing is found not in accordance with c gmp guidelines and regulations.
US FDA has not promulgated sepatately c gmp guidelines for combination products. Combination product is mostly a set of different products like medical device and a drug product therefore they are required to qualify respective gmp guidelines during their manufacturing.
Where as US FDA has drafted separate current good manufacturing practices guidelines for combination product in 21 CFR Part 4.
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