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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.
Biological-risk-eval-and-mngmnt-for-md-130x160

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 16

Pharmacy Compounding Regulation: Deconstructing Latest Guidance, Compliance & Enforcement Activities

Oct 17

Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus

Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

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

Editor's Picks

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Transseptalsolutions_logo

Transseptal Access System Cleared by FDA

The device includes a sheath, dilator and flexible puncturing needle, with a radiopaque loop wire at the sheath’s end.
Roche

Roche’s Hemlibra Receives Expanded FDA Approval

The agency previously approved the treatment for adults and children with hemophilia A with factor VIII inhibitors.
FDAnews Device Daily Bulletin

Federal Circuit Junks Boston Scientific Win in Stent Patent Fight

Aug. 24, 2012
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The Federal Circuit said Wednesday that a lower court had incorrectly constructed patent claims when it found that Boston Scientific Corp. hadn't infringed an inventor's patents on coronary stents, tossing a ruling of noninfringement and remanding the case for a second time.
Law360