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Positive Data on Pfizer/BioNTech Combo Vaccine

[ Price : $8.95]

Pfizer and BioNTech announce positive topline results from their Phase 1/2 study that is evaluating the safety, tolerability and i...

Olympus Recalls Insufflation Units

[ Price : $8.95]

Olympus recalls its high-flow insufflation units (model UHI-4) that are used in laparoscopic surgeries after receiving reports abo...

Breakthrough Device Changes Needed: Research

[ Price : $8.95]

Researchers from several U.S. academic medical centers suggest steps FDA and CMS could take to tighten CMS supplemental reimbursem...

Draft Guide on Remote Interactive Evaluations

[ Price : $8.95]

Federal Register notice: FDA releases a draft guidance entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresear...

Qiagen, Myriad Partner on Cancer Diagnostics

[ Price : $8.95]

Qiagen and Myriad Genetics announce a collaboration to develop cancer companion diagnostic tests.

Consolidated OPDP Untitled Letters Page

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion launches a new Web page to display untitled letters issued for drug advertising and pr...

Add Device Identifier to Medicare Forms: Senators

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Sens. Grassley and Warren urge FDA to quickly voice its support for including a device identifier on Medicare claims forms.

GSK Seeking Expanded RSV Vaccine Use

[ Price : $8.95]

After reporting favorable study data in those aged 50-59 years, GSK says it will seek FDA approval for an expanded use of Arexvy (...

Info Collection on Public Health Projects

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Standardized Reporting Forms for FDA Federal...

CDER Made Erroneous Statements to A/C: Letter

[ Price : $8.95]

Three developers of the Intarcia Therapeutics ITCA 650 drug-device implantable product to improve glycemic control accuse CDER off...