Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

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Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. That guidance document was updated in September 2021 to include 25 questions.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.

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Agency IQ

SEPTEMBER 29, 2023

AgencyIQ / FDA October 1 PAHPA Authorization lapses Unless reauthorized by Congress – and at this point, it’s looking unlikely – programs operating under the authority of the Pandemic and All-Hazards Preparedness Act and requiring reauthorization will cease to exist as of the start of the fiscal year. This is what OIRA is currently reviewing.

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Agency IQ

OCTOBER 27, 2023

What we expect to be talking about in November and December: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. Government shutdown: At present, the U.S.

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Agency IQ

DECEMBER 1, 2023

What we expect to be talking about in December and January: Diversity Action Plan guidance : There is perhaps no guidance that FDA is working on that is as hotly anticipated as its Diversity Action Plan (DAP) guidance, which is set for release anytime between now and December 29. This is what OIRA is currently reviewing.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. FDA has proposed to amend the 503A Bulks List by placing additional bulk drug substances on the list.

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