21
Mar

ADE Relief During Pandemic – But Only if You Need It!

The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency.  The FDA issued this Guidance directly with no public comment on March 20, 2020.  It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]

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20
Mar

COVID-19 Guidances to Bypass Initial Public Comment Period

In a prepublication notice in the Federal Register published today (here), the FDA indicates that, since the COVID 19 pandemic has resulted in the declaration of a public health emergency by the President, and, through the regulatory authority given to the Secretary of Health and Human Services, the FDA will expedite important guidance on COVID […]

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18
Mar

Mission Critical Only Inspections Starting on March 19

On March 10, 2020 FDA announced it was postponing all foreign inspections and on March 18, 2020, only 8 days later, FDA announced it was also stopping all domestic inspections unless mission critical until such time as it is deemed safe for FDA employees and their families as well as the employees of the firms […]

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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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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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06
Dec
Training Fundimentals

Training Fundamentals: Important to Baseball and the Analytical Laboratory

Training Fundamentals: Important to Baseball and the Analytical Laboratory By Tim Rhines, Ph.D | December 6, 2019 | Compliance, FDA, Laboratories, Science & Technology |  3 | Baseball season ended over a month ago, and I am already looking forward to when teams report for spring training.  At this time, team management is evaluating where the team succeeded and where improvement is needed.  It […]

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