23
Mar

FDA to Exercise Enforcement Discretion for Certain Limited REMS ETASU Elements

Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]

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18
Mar

COVID-19 and Impact for Ongoing Clinical Trials – FDA Provides Guidance

With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about […]

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17
Mar

Flow Restrictor Recommendations for Oral Liquid Products

Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers.  We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well.  Most of us think […]

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04
Mar
Businessman Running Along The Corridor

NDA Guidance on Pancreatic Enzymes is Withdrawn

While it is no surprise, the prepublication notice in the Federal Register today (here) announces the withdrawal of the FDA guidance Exocrine Pancreatic Insufficiency Drug Products–Submitting New Drug Applications.  The announcement comes just 19 days prior to the date when these products can no longer be submitted as an NDA.  Remember, FDA had noted in […]

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27
Feb
Close-up medical syringe with a vaccine.

You Can Build a Wall, but Not Assure Vaccination Against Coronavirus Will Be Affordable for All?

Reports of Secretary Azar’s comments regarding not being able to assure affordability of vaccination for all is a sign of the times we live in now.  Now, I agree that a pharmaceutical company that can develop a vaccine to this deadly virus should be compensated fairly, but, if the United States fails to assure the […]

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21
Feb
Colored skittles with different sizes

Less is More!

Today, the FDA published in a final rule (here) a significant revision to the regulatory definition of biological product that will have a major impact on what product will be regulated under the Public Health Service Act (PHSA), and which will be regulated solely under the Federal Food, Drug, and Cosmetic Act (FFDCA).  Specifically, the […]

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19
Feb
Road sign message - Change just ahead

Is your NDA a BLA?  March 23rd is Quickly Approaching….

Our own Keith Webber originally provided very detailed information and helpful hints in his August 2019 blog (here) regarding FDAs transition of certain NDAs to BLAs under the BPCI Act. So, although this may not be “new” news, we think it’s worth a quick trip down memory lane, as the implementation date quickly approaches.  Let’s […]

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14
Feb
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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