Drug Device Combination Products | Episode 02 - Regulatory Procedure for Combination Products in USA

Welcome to the PharmaCamp with Neha. This is a small initiative from my side to share knowledge about the pharmaceutical world and regulatory, as I feel education is the best gift one can receive or give back to society.
Are you a working professional who wants to upgrade your skills? OR a student who wants to make a career in pharmaceuticals? OR are you a person who is interested to learn about the regulatory systems? Then this TH-cam channel is for you.
About me:
I am Neha Parashar, working as a Associate Director in a pharmaceutical company and based in Germany. I am a passionate healthcare professional, an educator, and a mentor.
In this series 'Drug Device Combination Products', I will discuss the regulatory aspects related to Combination products.
Channel Introduction- Welcome to PharmaCamp • Welcome to PharmaCamp ...
Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application
• Regulatory Learnings |...
Series 2-Regulatory Shorts
• Regulatory Shorts
Series 3-EU Marketing Authorisation
• EU Marketing Authorisa...
Series 4-Dare to Lead with Neha | An Interview Series with Pharma Leaders
• Dare To Lead - An Inte...
Series 5-Orphan Drug Development
• Orphan Drug Development
LinkedIn: / neha-parashar
LinkedIn Articles on various Regulatory Topics:
1. Regulatory Pathways for Expedited Access of Medicines / regula. .
2. Step-wise Regulatory approach for the Paediatric drug Development / step-w. .
3. Designing the Global Regulatory Strategy for the Development of Orphan Medicinal Products
/ design. .
4. Step wise approach for Quality Risk Management (QRM) in pharmaceutical industries / step-w. .
5. Step-wise regulatory approach for the assessment of process related impurities in biological products / step-w. .
6. Step-wise approach for sterilisation package preparation in regulatory dossiers for biologicals and other liquid sterilised products / step-w. .
7. Step-wise approach for regulatory risk assessment of adventitious agents in biologicals products / step-w. .
8. Five Step Approach to Assess Equivalency Requirements of Topical Products / five-s. .
Disclaimer- This video channel is for educational purposes. These are purely my views and not any recommendations. The channel does not represent the views of the organization I am associated with, and it has no connection with my current organization.

[@pharmajobalert2933]

😍

[@ankurgeete1235]

Good and the best. Very informative

[@pharmacamp]

Thank you 😊

[@nileshbawane842]

Well done Neha

[@pharmacamp]

Thanks Nilesh

[@hemanthkg4657]

This is informative! Thank you Neha, for the new series on combination products.
I was wondering will the procedure remain the same for generic combination products?

[@pharmacamp]

Thanks Hemanth,
General regulatory framework for combination products applies to generic products as well, however in addition there may be specific requirements for generic combination products that are not applicable to brand-name combination products.
The USFDA regulates generic drug-device combination products under the ANDA process. The ANDA process allows generic drug manufacturers to seek approval for products that are the same as a previously approved brand-name drug. However, in the case of drug-device combination products, the ANDA process may not be appropriate, as the device component may have a significant impact on the safety and efficacy of the product.
Therefore, for generic drug-device combination products, the FDA may require additional testing and documentation to demonstrate the safety and efficacy of the product.

[@prabhaharansankaran1493]

Thank you for insightful sharing. Could you please let me know for PFS 510K is required in US ?

[@pharmacamp]

Thanks Prabhaharan. As your PFS might be having drug/biologicals and the primary mode of action will be due to drug/biological, therefore in this case you don't need 510K, however we need to submit the NDA/BLA as applicable for our drug/Biological.

[@prabhaharansankaran1493]

​@@pharmacamp Thank you for the clarifications.. in case of co packaged combination product for example lyo drug filled vial and PFS filled with Wfi for dilution. In this case PFS filled with Wfi requires 510k or only technical documents required from PFS manufacturer for filing ?