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The FDA is considering changes in its regulations for analyte specific reagents, Steve Gutman, the director of the agency’s Office of In Vitro Diagnostic Device Evaluation and Safety, part of the Center for Devices and Radiological Health, this week.

The FDA’s ASR regulations were written in 1997 and enacted in November 1998 (read the original document here).

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Researchers are developing a breath test to determine how severe patients' methylmalonic acidemia disease is, FierceBiotech reports.

NPR reports that vaccine developers are working on SARS-CoV-2 vaccines that are easier to store or administer than the current crop.

Reuters reports that France is to recommend that people under 55 who received one dose of AstraZeneca's SARS-CoV-2 vaccine receive a different vaccine for their second dose.

May
05
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Adverse drug reactions (ADRs) are responsible for around 5 percent of hospital admissions and occur in 6 percent to 15 percent of hospital stays.