On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for.
Saturday, January 9, 2021
The U.S. Food and Drug Administration had a busy 2020, as detailed in earlier blog posts. This blog post explores politics and a few policy activities we’ll be keeping an eye on in 2021 and how they might impact medical product manufacturers, particularly now that we know the U.S. Senate will be controlled, like the U.S. House of Representatives and the White House, by Democrats.
Politics
Chairmanship of the powerful House Energy & Commerce Committee, which has jurisdiction over FDA, remains with Rep. Frank Pallone of New Jersey while Senator Patty Murray of Washington is in line to helm the Senate Health, Education, Labor, and Pension (HELP) Committee. While President-elect Joe Biden has announced his picks for Secretary of Health and Human Services (California Attorney General Xavier Beccera) and Director of the Centers for Disease Control and Prevention (Rochelle Walensky, chief of the Infectious Diseases at Massachusetts General Hospital
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What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some w
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What a year for the Food and Drug Administration! FDA, an agency
with regulatory oversight of 20-25% of products on which consumers
spend, including food and medicines, but which typically stays out
of the limelight, was thrust into the public eye amidst the
COVID-19 pandemic. This was the year many Americans became familiar
with lesser-known and niche policies like those governing emergency
use authorizations (EUAs) and with the role of FDA in regulating
laboratory developed tests (LDTs). The agency also took some flak
for seeming to bow to political pressure in authorizing
Tuesday, December 15, 2020
What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was thrust into the public eye amidst the COVID-19 pandemic. This was the year many Americans became familiar with lesser-known and niche policies like those governing emergency use authorizations (EUAs) and with the role of FDA in regulating laboratory developed tests (LDTs). The agency also took some flak for seeming to bow to political pressure in authorizing hydroxychloroquine for emergency use as a potential COVID-19 treatment, then rescinding the authorization, as well as for its less-than-accurate pronouncements of positive data concerning convalescent plasma treatment. These were reminders that the agency Americans trust to protect the public does get things wrong sometimes and is susceptible in some ways to political press