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Gmp-inspection-preparation-checklist-130x160

GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Events

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Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

Nov 1

Brexit and the Impact to Your Global Business Operations: What Life Sciences Companies Need…

Nov 7

FDA’s New Biosimilars Plan: CBER’s New Policy and the Impact on Pharmaceutical Stakeholders

Editor's Picks

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Congress

Senators Question Digital Health Pre-Cert Program

The agency “should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states.
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OssDsign’s Regenerative Cranial Implant Cleared by FDA

The implant’s ceramic component resorbs and is eventually replaced by bone through the healing process.
FDAnews Drug Daily Bulletin

IMMUNOGEN, INC. GRANTS BIOTEST AG RIGHTS TO USE IMMUNOGEN TAP TECHNOLOGY

July 12, 2006
KEYWORDS FDAnews Drug Daily Bulletin
A A

ImmunoGen, Inc. announced today that the company has entered into an agreement that grants Biotest AG exclusive rights to use ImmunoGen's Tumor-Activated Prodrug (TAP) technology with antibodies targeting an undisclosed target to develop novel anticancer therapeutics. Under the agreement, ImmunoGen will receive a $1 million upfront payment, up to $35.5 million in potential milestone payments, and royalties on the sales of any resulting products.

PipelineReview (http://www.pipelinereview.com/joomla/content/view/5098/118/)