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ICH Presentation on Selective Safety Data Collection

[ Price : $8.95]

The International Council for Harmonization posts a presentation outlining its finalized guidance entitled A Selective Approach to...

Positive Results in AZ Breast Cancer Trials

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AstraZeneca reports positive results from two trials evaluating new breast cancer treatments.

Rare Disease Endpoint Pilot Program

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Federal Register notice: FDA launches a Rare Disease Endpoint Advancement Pilot Meeting Program.

CGMP Violations at Nephron SC

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FDA warns West Columbia, SC-based Nephron SC about CGMP and other violations at its drug manufacturing facility.

Panel Reviewing Ipsen NDA Postponed

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FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and v...

CGMP, Other Violations at Advanced Cosmetic Lab

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FDA warns Chatsworth, CA-based Advanced Cosmetic Research Laboratories about CGMP violations and marketing of misbranded unapprove...

Jubilant Generics FDA-483

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FDA releases the form FDA-483 with six observations from an inspection at Indias Jubilant Generics.

NeuroOne Medical Brain Electrodes Get Clearance

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FDA clears a NeuroOne Medical Technologies 510(k) to market its Evo sEEG Electrode technology for temporary (less than 30 days) us...

Imjudo/Imfinzi Approved for Liver Cancer

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FDA approves AstraZenecas Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for treating adult patients with unresect...

Guide on ANDA In Vitro Permeation Studies

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Federal Register notice: FDA makes available a draft guidance entitled In Vitro Permeation Test Studies for Topical Products Submi...