FDA Expected To Rule On Mercury Dental Amalgams

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I'm so glad that I don't have mercury fillings in my mouth anymore. Unfortunately, I've got a mouthful of crowns, and precious little left of my natural teeth. I ran across this press release, and thought you'd be happy to know that the FDA is expected to rule on mercury-containing dental amalgams, "Resolution to Study Phase Out of Mercury Tooth Dental Fillings Receives 16% of Vote at Danaher Shareholder Meeting." The press release states, "Some-time in late July, the Food and Drug Administration is expected to rule on the use of mercury amalgam. The Consumers for Dental Choice won a 10-year battle with the FDA to comply with the law and set a date to classify mercury amalgam." 

Related Posts: Caution - Teeth Whiteners Can Reduce Enamel Strength Mercury-Containing Dental Fillings - Health and Environmental Concerns 

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FDA GCP - Tips On Conducting non-US Studies

If you're looking to conduct clinical studies outside the U.S., you might do well to read this superb article from Bruce Mackler on GEN, "Spotlight on the FDA Outsourcing Clinicals; Medical Journal Articles; and Contract Manufacturing Liability Issues. Mackler says, "In today’s financing environment, the absence of early clinical data presents a high barrier to obtaining funding. Investors often say “show me the clinical data that show that the drug is safe and works and I will show you my money.” As a result, biopharma companies have moved into early non-U.S. clinical trials that have lower safety data burdens. These studies are being conducted in less wealthy (a.k.a., developing) countries, where Phase I trials can be more rapid and less costly. This strategy has been promoted by CROs established in these countries." The article provides some great tips, not to be overlooked. 

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The FDA Drug Approval Process - free video

Updated May 23, 2025

The original link broke.

You might also be interested in the following FDA video:

https://youtu.be/fZ-Msidi7EE?si=rzphqPYBxwWlPgxV

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For those of you wanting something a little more in-depth, here's this free 24 minute video, produced by peRX (prescribing evidence-based therapies), "Why and how are drugs approved?" Here's what the video presents . . .

1. Overview of drug research and development in the United States, and
2. The FDA drug approval process

A side note about peRX and this video. The peRX site states, "On May 13, 2004, Warner-Lambert, a division of Pfizer, Inc., entered into an Assurance of Voluntary Compliance/Discontinuance with the Attorneys General of 50 States and the District of Columbia to settle allegations that Warner-Lambert conducted an unlawful marketing campaign for the drug Neurontin® that violated state consumer protection laws. Among other things, the settlement provides for a $21 million Consumer and Prescriber Education grant program." The peRX Project is an educational program funded by the Consumer & Prescriber Education grant program.

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The FDA Drug Approval Process

Updated July 15, 2020

The link in the original post broke.

You might also be interested in this:
Development & Approval Process | Drugs (on the FDA.gov website)

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I always have to remind myself what's involved in getting a drug to market. This eSSORTMENT article is short, sweet, and a great overview of the process, "The FDA drug approval process - The FDA has an elaborate clinical process that examines new drugs for distribution to the public with its seal of approval." I've seen it stated in some other places I've read, that it can take about 15 years to 'birth' a new drug.

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