Articles by David Amor

  1. Usability’s Importance In Combination Products: The Mylan Citizen Petition Case Study 10/25/2016

    Citizen petitions often are submitted to question or persuade FDA to examine product safety issues, but they also have been abused to prevent products from reaching market. Sharp attention to usability and human factors can give you the upper hand, though, if your company is targeted by this underhanded strategy.

  2. Understanding Medical Device QMS Requirements For Combo Products: Medical Device Company Edition 6/27/2016

    This article is the second in a two-part series focusing on 21 CFR Part 4 requirements for drug-device combination product manufacturers. This article examines what medical device companies with a QMS compliant to 21 CFR 820 need to comply with from the 21 CFR 210/211 (pharma/ drug) side. 

  3. Understanding Medical Device QMS Requirements For Combo Products: Pharma Company Edition 3/14/2016

    In the spirit of reducing the QMS burden on companies developing combination products, FDA acknowledged that there is no need for redundant cGMP requirements that are analogous between drug and device regulations. That said, drug companies should understand the implications of the required 21 CFR 820 subparts, and why they were deemed critical enough to consider for implementation.

  4. How To Determine A Combination Product’s Primary Mode of Action (PMOA) 1/22/2016

    While principal mode of action may be easy to determine for some combination products, others - particularly those with multiple indications for use - can be much trickier. Here's how to determine the most appropriate PMOA, and corresponding regulatory pathway, for your combination product. 

  5. A Primer On Investigational Drug/Delivery Device Regulatory Requirements 11/16/2015

    Combination drug/device delivery products are becoming the standard of care in many therapeutic areas, but a cloud of confusion persists surrounding investigational products: What are the requirements for drug/delivery devices used in clinical trials?