Blog Diagnosis Government Individual 
FDA Law Blog
DECEMBER 4, 2023
The government asserted additional allegations that are outside our scope. Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Zarzamora Press Release.
FDA Law Blog
MAY 19, 2025
For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. Attorneys Office, Northern District of Illinois, April 21, 2025. 81, 86, 251. 81, 89, 251.
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FDA Law Blog
JANUARY 6, 2022
220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §
FDA Law Blog
JANUARY 6, 2022
220 and was described on HP&M’s blog here. C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. §
FDA Law Blog
NOVEMBER 18, 2021
The tests are very accurate in detecting individuals with a relatively high viral load (symptomatic or not). PCR) test is considered the gold standard for actual diagnosis. On the minus side, a rapid antigen test may miss an infected individual with a low viral load (e.g., A positive result, however, is treated as a screen.
FDA Law Blog
MARCH 15, 2023
See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). A reader may miss a cancerous lesion if the image quality is poor, resulting in a false negative diagnosis, which could delay treatment and result in an avoidable death.
FDA Law Blog
OCTOBER 17, 2023
In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA recognizes the existence of barriers that may hinder underserved populations from receiving medical treatment or diagnosis.
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