FDA (can also be expanded as the Food and Drug Administration) is a bureau that administers the public’s welfare by controlling and surveillance of food products, medications, vaccines, medical devices, etc. There are certain rules and criteria for post marketing safety reporting of FDA combination products.
What are combination products?
As per FDA’s guidelines, an FDA combination product can be defined as a combination comprising an individual drug, device and biological product. Combination products are created to provide clinical benefits to humankind. With each day passing by, the increase in combination products submission poses a challenge for the authorities to make it effective and safe. Some examples of combination products include auto-injectors, syringes, pen injectors etc.
Different categories of combination products
A combination product includes products such as:
- Single entity combination products- It refers to the products that combine two or more constituent components in a sole identity as its own—basically a combination of drug and device, drug and biopharmaceutical, drug, device and biologic, etc. Varied examples consist of pens (capable of insulin injection) and syringes.
- Co-packaged combination products- These products combine two or more individual packages in a single package. It is essentially either a blend of drug and device, device and biologic or drug and biopharmaceutical together in a single package. Some examples include first aid and surgical kits.
- Cross labelled combination products- FDA combination products include cross labelled combination products which comprises drugs, device, biopharmaceutical separately. Each assigned under a specific label for specific purposes. It can be regulated only on the approval of the proposed product—for example, a specific device required to use a drug.
All these FDA combination products are intended only to use for health purposes and are directed for the safety of an individual.
POSTMARKETING SAFETY REPORTING FOR COMBINATION PRODUCTS
- The applicants must stick to the guidelines for reporting FDA combination products. They must abide by the requirements of their products type. One must perform tasks in accordance with the requirements.
- They must specify the event’s relevance with the constitute components or the combination product as a whole. It also must be ensured of safety reporting of the combination product.
- Constituent part applicant must share information regarding event of death or serious injuries and must share with other applicants within 5 days.
PMSR for combination products allows the safe reporting process after approval. More and more companies are coming forward to invest in combination products. It provides effective, safe and affordable options to patients.