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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

Events

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Sep 19

Clarity on Clinical Investigations: What You Need to Know About EU-MDR and ISO/DIS 14155:2018

Sep 24

Drug Regulation in China: Updates, Key Issues and Common Challenges

Sep 25

The AI Revolution: What You Must Know About Medical Imaging Regulation

Sep 27

Using IT to Improve Data Integrity: Optimizing Your Compliance Joint IT/QA Programs

Sep 27

FDA and EU Inspections — The Mutual Recognition Agreement: What’s Next?

Oct 1

Advanced GMP Training: The Seven Essentials for Compliance

Editor's Picks

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Abbott Receives European Approval for Two Pediatric Devices

The devices have already received FDA clearance.
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Thirteen States Support Ohio Attorney General’s Bid to Block Bellwether Opioid Trial

“States are in the best position to enter into global settlements and to protect all communities through statewide implementation of policy and ensuring equitable distribution of available funds,” one brief stated.
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/)