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FDA OKs Breakthrough Colorectal Cancer Test

[ Price : $8.95]

FDA approves Geneoscopys colorectal cancer stool-based screening test ColoSense for those aged 45 years and older with an average ...

Lilly Gets 6/10 Panel Date for Alzheimers BLA

[ Price : $8.95]

FDA announces a 6/10 Peripheral and Central Nervous System Drugs Advisory Committee meeting to vote on an Eli Lilly BLA for Alzhei...

Guide on REMS Logic Model

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With A...

House Committee Pressures FDA on China Oversight

[ Price : $8.95]

The House Oversight Committee puts pressure on FDA and its oversight of imported Chinese and other foreign active pharmaceutical i...

Multiple Violations in Bioptimal Inspection

[ Price : $8.95]

FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters....

CDRH Product Evaluation/Quality Office Modified

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Federal Register notice: FDA announces that CDRH Office of Product Evaluation and Quality has modified its organizational structur...

FDA OKs TE Code for Paclitaxel Suspension

[ Price : $8.95]

FDA approves an AB therapeutic equivalence code for cancer drug paclitaxel suspension and tells HBT Labs it must formally apply fo...

J&J Reports Favorable TAR-200 Clinical Data

[ Price : $8.95]

A Phase 2b clinical study evaluating Johnson & Johnsons investigational TAR-200 monotherapy in nonmuscle-invasive bladder cancer p...

GlycoMimetics Phase 3 Leukemia Study Fails

[ Price : $8.95]

GlycoMimetics says its Phase 3 study of uproleselan plus chemotherapy in acute myeloid leukemia patients did not achieve a statist...

REMS Logic Model Draft Guidance

[ Price : $8.95]

FDA posts a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment" to help applicants with ...