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Human Drugs

Drug Quality Metrics Reporting Begins 2018 [Correction]

FDA Webview corrects a 6/22 article on FDAs quality metrics program that wrongly attributed the DIA presentation to CDER Office of Surveillance acting...

Marketing

Questions Raised on TV Show Drug Product Placement

Researchers question the impact of Incytes tie-in with the television daytime drama General Hospital during Rare Disease Month.

CTTI Releases Mobile Tech Tools, Recommendations

The Clinical Trial Transformation Initiative issues recommendations and tools for using mobile technology data in clinical trial endpoints.

Medical Devices

Quidel Gains Clearance for Sofia RSV Immunoassay

FDA clears a Quidel 510(k) for the Sofia RSV Fluorescent Immunoassay to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detect...

Human Drugs

Draft Guide on Medical Gas GMPs

FDA posts a draft guidance on Current Good Manufacturing Practice for Medical Gases.

FDA General

House Subcommittee Advances Flat FDA Budget

The House Appropriations Subcommittee on Agriculture/FDA advances to the full committee an FDA funding bill that provides almost $2.8 billion ($4.473 ...

Human Drugs

Acting Chief Scientist Borio on Detail at White House

FDA acting chief scientist Luciana Borio accepts a one-year detail with the National Security Council to assist with medical and biodefense preparedne...

Human Drugs

PharMEDium Recalls Compounded Drugs Due to Hospira Recall

PharMEDium Services recalls specific lots of potassium phosphate and succinylcholine chloride due to a lack of sterility assurance.

FDA General

Califf Touts New Duke Center

Former FDA commissioner Robert Califf describes the work of a new Duke University center looking at ways to turn academic analyses of health data into...

Human Drugs

FDA Promoting Generic Drug Competition

FDA publishes a list of off-patent, off-exclusivity drugs that have no generic alternatives to promote development of less expensive options for consu...