Accelerated Approval


With One Controversial Drug for Alzheimer’s on the Market, Another’s Study Did Not Impress

There is no question that the Alzheimer’s drug Aduhelm has stirred up a lot of controversary.  The action that CMS took related to reimbursement for the drug for Medicare patients and the initial yearly projected cost soured many stakeholders on the product, from prescribers to patients, as well as caregivers and healthcare providers, not to […]

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Sockeye Salmon Jumping Up Falls

Between a Rock and a Hard Place – Accelerated Approval for Alzheimer’s Drug Brings Cheers and Jeers!

Three FDA Advisory Committee members resigned over the FDA’s decision to grant accelerated approval to aducanumab for treating Alzheimer’s Disease.  One member said, when he resigned, that “this is the worst decision the FDA has ever made.”  I get it.  When the entire committee voted against approval (full approval), the FDA kind of backdoored its […]

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Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

CBER Publishes a Boatload of New Gene Therapy Guidances

  January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents!  A total of six final guidelines and one draft guideline on GT products were issued.  These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]

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Accelerated Approval of Hydroxyprogesterone for Delay of Preterm Labor Image

Compounding vs. FDA Approved Product Presents a Conundrum Regarding the Accelerated Approval of Hydroxyprogesterone for Delay of Preterm Labor

Sue Sutter of the Pink Sheet wrote an article on September 23 entitled “Makena’s Accelerated Approval Will Hang In Balance at US FDA Panel Meeting In October” (here [subscription required]).  The crux of the article deals with how FDA will handle accelerated approval when the required postmarketing confirmatory study fails to meet its endpoints.  Ms. […]

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