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FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE DEVICE TO DETECT AND MEASURE NON-MICROBIAL ANALYTES TO AID IN THE DETECTION AND IDENTIFICATION OF LOCALIZED HUMAN INFECTIONS

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analy... Read More


FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE DEVICE TO DETECT AND IDENTIFY MICROBIAL NUCLEIC ACIDS BY FLUORESCENCE IN SITU HYBRIDIZATION IN CLINICAL SPECIMENS

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic ... Read More


FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; IMMUNOLOGY AND MICROBIOLOGY DEVICES; CLASSIFICATION OF THE DEVICE TO DETECT NUCLEIC ACIDS FROM NON-VIRAL MICROORGANISM(S) CAUSING SEXUALLY TRANSMITTED INFECTIONS AND ASSOCIATED RESISTANCE MARKER(S)

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Mi... Read More


FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES; CLASSIFICATION OF THE BREAST MILK MACRONUTRIENTS TEST SYSTEM

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test S... Read More


FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES; CLASSIFICATION OF THE VORICONAZOLE TEST SYSTEM

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System. The ru... Read More


FOOD AND DRUG ADMINISTRATION ISSUES RULE: NEW ANIMAL DRUGS; APPROVAL OF NEW ANIMAL DRUG APPLICATIONS; WITHDRAWAL OF APPROVAL OF NEW ANIMAL DRUG APPLICATION; CHANGE OF SPONSOR

WASHINGTON, May 9 -- Food and Drug Administration has issued a rule called: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of... Read More


Clinical Trial: Effectiveness of Treatments for Cirrhosis With Varicose Veins

U.S., May 9 -- ClinicalTrials.gov registry received information related to the study (NCT06961474) titled 'Effectiveness of Treatments for Cirrhosis With Varicose Veins' on April 29. Brief Summary: L... Read More


Clinical Trial: An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function

U.S., May 9 -- ClinicalTrials.gov registry received information related to the study (NCT06962774) titled 'An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participan... Read More


Clinical Trial: Test of Target Engagement of Ambiguity Aversion

U.S., May 9 -- ClinicalTrials.gov registry received information related to the study (NCT06962527) titled 'Test of Target Engagement of Ambiguity Aversion' on Jan. 27. Brief Summary: The present work... Read More


Clinical Trial: Bone Metabolism in Premenopausal Exercising Women

U.S., May 9 -- ClinicalTrials.gov registry received information related to the study (NCT06961773) titled 'Bone Metabolism in Premenopausal Exercising Women' on March 06. Brief Summary: The main goal... Read More