If you think that getting a medical device onto market is a long and tedious process, be glad you don’t have to deal with the biologics license application timeline.
It sometimes seems possible to raise a child and send him/her off to college in less time than it takes to bring a new drug to market. 😕
But this lengthy and highly-regulated process has resulted in a market with some of the safest drugs, vaccines and therapeutics in the world.
Per 21 CFR 600 – 680, the process of filing a Biologics License Application (BLA) is a long one, with each phase of development requiring years of clinical trials and studies.
Just the research and discovery phase of biologic development can take up to eleven years, and all that gets you is an Investigational Drug (IND) application submitted to the FDA.
Sure, you can start your Phase I clinical trials while the FDA evaluates your IND, but trials require three separate phases that can take months or years to complete, depending on the product.
At the end of your Phase III trial, you can submit your BLA to the FDA, but it can still take up to two years to gain approval.
And biologics are held to a stringent post-market surveillance requirement, referred to as Phase IV of the trials – and only half in jest.
The biologics license application timeline leads pharmaceutical companies to develop robust R+D programs that will (hopefully) support the long-term business strategies and financial goals of the organization.
Talk about your long-range planning. That 300 days required for FDA review of your PMA submission doesn’t seem quite so bad now, does it? 😉
Still want to know more about the BLA process? Biologics – Regulatory + Quality Assurance | Michelle Lott | lean RAQA
Or you can check out our podcast on Apple iTunes, Spotify or Soundcloud: https://soundcloud.com/raqatoday/fda-device-downclassification-this-is-not-good-news
