2016 Illness Individual Manufacturing 
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.
Alabama Academy of Family Physicians
FEBRUARY 20, 2025
In 1996, a variant of H5N1 was documented overseas that resulted in a severe illness in birds and was designated as highly pathogenic avian influenza (HPAI). Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. However, the 68 human cases in the U.S.
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