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Meridian Bio EUA for Covid Assay

[ Price : $8.95]

FDA grants Meridian Bioscience an emergency use authorization for its Revogene SARS-CoV-2 assay, a molecular diagnostic test for t...

Kalo Paying $12.7 Million to End False Claims Case

[ Price : $8.95]

The Justice Department says kalo is paying $12.7 million to resolve a whistleblowers allegations that it induced false claims for ...

Vektor Medical 510(k) for ECG Mapping Tool

[ Price : $8.95]

FDA clears a Vektor Medical 510(k) for vMAP, a computational electrocardiogram mapping system for use to improve outcomes in ablat...

Regulatory Review Period Determined for Dojolvi

[ Price : $8.95]

Federal Register news: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Dojolvi (trihepta...

Info Collection: Antimicrobial Distribution Reporting

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Antimicrobial Animal Drug Distribution...

Biogen Probes Fatal Case of Aduhelm Patient

[ Price : $8.95]

Biogen says it is investigating the death of a 75-year-old patient who had taken the companys controversial Alzheimers drug Aduhel...

Shorter Antibiotic Use Effective in 2 Uses: Studies

[ Price : $8.95]

FDA says research it funded demonstrated that in two contexts shorter courses of antibiotic treatment were as effective as longer ...

CHPA Recommendations for Implementation of Genus Decision

[ Price : $8.95]

The Consumer Healthcare Product Association recommends four steps FDA should take in implementing an appeals court decision on reg...

CGMP Violations at Adamson Analytical Labs

[ Price : $8.95]

FDA warns Adamson Analytical Laboratories about repeat CGMP violations in its work as a contract testing laboratory.

ORA Embraces Remote Evaluations in Post Pandemic Arena

[ Price : $8.95]

FDA Office of Regulatory Affairs assistant commissioner Elizabeth Miller tells an industry conference that her office has embraced...