12 Current news of FDA


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FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing


PerkinElmer, Inc. announced that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the Company’s New Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin using this kit ...


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Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization

Test results in three and half hours


Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples ...


High-risk cardiac devices are safe

Device 'supplement' applications are generally not accompanied by new clinical testing, with implications for patient safety


The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which manufacturers must collect preclinical and clinical data before the ...


Agilent Technologies and FDA Collaborate to Improve Testing for Salmonella

Project Also Seeks to Develop Better Tools to Test Truth of Seafood Labels


Agilent Technologies Inc. announced that it has entered into a Cooperative Research and Development Agreement with the U.S. Food and Drug Administration to develop new tools to detect and analyze pathogens in food. The joint R&D effort will also seek to improve DNA-based tools for confirming that ...


FDA Approves Roche’s HPV Test for Identifying Women at Highest Risk for Cervical Cancer


Roche announced that the US Food and Drug Administration (FDA) has approved the cobas HPV (Human Papillomavirus) Test which identifies women at highest risk for developing cervical cancer. This test will help physicians make early, more accurate decisions about patient care, which may prevent ...


FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets

Experts to Re-examine Guidance for Platelet Testing


Fenwal, Inc. announced that the U.S. Food and Drug Administration has cleared the Verax Platelet PGD(R) test as a quality control test to detect bacterial contamination in whole blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive global distributor of the test, which was ...


MOSAIQUES and U.S. FDA describe detection of drug-induced side effects in early phase animal models


Drug-induced toxicity represents a significant problem in health care delivery: Over 100,000 people die per year from adverse effects of medications in the U.S. (Starfield, JAMA 2000, 284: 483-485). This has led to an intense awareness of drug-induced side effects, which may hamper the ...


New POC allergy test has been cleared by FDA


The US medical agency FDA has granted Phadia the clearance to sell and market its new POC allergy test ImmunoCAP® Rapid product in US. “This is a historical event in the diagnostic industry since it is the first semi-quantitative POC allergy test that has been FDA cleared. It is a major ...


innovatis AG Bielefeld and Bayer Technology Services Leverkusen conclude strategic alliance

Online analysis for the biopharmaceutical industry


innovatis AG and Bayer Technology Services GmbH (BTS) have signed a cooperation agreement on production and global sales for BaychroMAT® system solutions. According to the company, with this technology developed by BTS and integration of innovatis equipment, process-critical parameters such as ...


Thermo Fisher Scientific Launches Program to Meet Melamine Detection Challenges


Thermo Fisher Scientific Inc. announced it has launched a program focused on assisting government and commercial food testing laboratories in the development and implementation of methods for the analysis of melamine in food products imported from China. This new program comes in response to the ...


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