The Direct Doctors Difference
AUGUST 18, 2021
According to DPC Frontier, a site owned by a DPC physician/lawyer who was a founder of the movement, there are now over 1500 clinics doing pure Direct Care across the nation. Looking back to 2014, when we began, there were less than 100. There are likely many more than have been officially labeled on the map.
FDA Law Blog
OCTOBER 14, 2024
The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. 2014); U.S. Stem Cell Clinic, LLC , 998 F.3d 3d 1314 (D.C.
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The Clinical Problem Solvers
JANUARY 18, 2021
Understand that collective action and a focus on community, rather than individualism, are most effective in combating racism and achieving health equity. One of the biggest barriers to health equity is the narrow focus on the individual and a failure to see health as a widespread community issue. Published June 10, 2014.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.
FDA Law Blog
MARCH 8, 2023
Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. eMDR submissions can be submitted in one of two ways: Health Level 7 Individual Case Safety Reports (HL7 ICSR) via AS2 (for high volume reporting) or by using FDA’s eSubmitter software (for low volume reporting).
FDA Law Blog
JUNE 29, 2022
In May 2014, FDA finalized a guidance document entitled “ Expedited Programs for Serious Conditions – Drugs and Biologics ,” (the Expedited Programs Guidance) This guidance noted that a “[d]esignation may be rescinded if it no longer meets the qualifying criteria for breakthrough therapy.” randomization, blinding).” Granted .
FDA Law Blog
JUNE 23, 2021
I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.
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