FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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FDA Law Blog

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.

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FDA Law Blog

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation.

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FDA Law Blog

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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GeriPal

MARCH 2, 2023

There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. I understand that it can be a hard place clinically. We should be able to trust all the data that comes from our governing board. The whole focus was to reduce antipsychotic prescribing. But we should highlight that.

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Common Sense Family Doctor

MARCH 23, 2025

Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency. We make evidence that other groups use to make guidelines"), the passage of the Affordable Care Act made AHRQ a target again in 2012, when a House appropriations subcommittee voted to zero out its budget again.

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GeriPal

APRIL 17, 2025

Now to the federal government that is going way beyond what I think people truly understand. Alex 20:58 Farah, appreciate the medicine metaphor for our clinical audience. So Shalonda Young was the very first black woman to serve as the OMB director in charge of the federal government’s budget. Well played.

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