Drugmakers Seeking Approval Under FDASIA Must Keep Manufacturing In Mind; FDA

By Gareth Macdonald

- Last updated on GMT

Related tags: Food and drug administration, Medicine

Drugmakers seeking approval under FDASIA must keep scale-up in mind
Drugmakers seeking approval under FDASIA must keep scale-up in mind
Planning for manufacturing scale up is a critical step that biotech drug developers often overlook according to US FDA Commissioner, Margaret Hamburg. 

Dr Hamburg made the comments at the annual meeting of the Massachusetts Biotechnology Council last week during an address that examined the factors shaping innovation in the drug industry, including the 2012 FDA Safety and Innovation Act (FDASIA).

She said that while FDASIA had created an expedited pathway for candidate therapies whose preclinical data suggests they may be better than existing therapies, biotech start-ups need to look beyond development in the lab when seeking approval.

No matter how good your data and how important the unmet need, approval also hinges on whether you have a manufacturing facility ready to go and a plan in place for scaling up production so you can manufacture your new drug and do so in a reliable, high quality facility.

Sadly,” ​Hamburg continued “too many start-up companies fail to recognize this fundamental fact, and so approval is delayed​.”

She added that to date to date the FDA has received a total of 31 breakthrough therapy designation requests, of which nine have been granted, ten have been denied, 11 are pending, and one has been withdrawn.

For those companies that are interested in knowing more about these various expedited development and review programs, we’re currently developing a guidance document that will describe each program and explain the criteria for each program -- including what we mean by such concepts as “available therapy,” “unmet medical need,” and “serious condition​.” 

Related topics: Markets & Regulations, Regulations

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