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Latest FDA News and Information
FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist
The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children... read more
FDA Approves Drug for Chronic Drooling in Children
The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.
New Early Detection System Helps FDA Identify More than 100 Food Safety Problems in First 7 Months
More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration?s new electronic portal in its first months of operation, the agency said... read more
Federal Agents Seize FastSize Extenders and FastSize EQM Erectile Quality Monitors
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $346,954.43 worth of FastSize Extender devices and FastSize EQM Erectile Quality Monitor devices, as well... read more
Food and Drug Adminstration (FDA): CDRHNew
Summary Information for: OraQuick HCV Rapid Antibody Test
Labeling, Approval Order, and Summary of Safety and Effectiveness for OraQuick HCV Rapid Antibody Test (P080027).
Consumer Information on: OraQuick HCV Rapid Antibody Test - P080027
The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against... read more
Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period
The FDA is reopening until 9/7/2010, the comment period for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents... read more
Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors
The FDA is requiring nine companies to conduct a postmarket surveillance study on positive displacement needleless connectors to assess whether they may be associated with a higher rate of device-associated... read more
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Medical Device Recall: Cobe Spectra Apheresis System Disposable Tubing Sets
Reports of leaks at the return luer connection on two (2) lots of COBE Spectra White Blood Cell disposable tubing sets. WBC Set, Spectra, Functionally closed WBC Set, Spectra.
