Tag Archive: FDA

IND Safety Reporting

FDA’s Safety Assessment for IND Safety Reporting Draft Guidance

Bart Cobert examine's the FDA's latest guidance on Safety Assessment for IND Safety Reporting

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FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development – Safety

Bart Cobert reviews the FDA Draft Guidance: Best Practices for Communication with FDA during Drug Development, and how it relates to safety.

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SAE Reporting for Outsourcing Facilities (Compounders)

Bart Cobert reviews the FDA guidance on AE Reporting for Outsourcing Facilities (Compounders)

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Bart’s Corner: Preparing and Coding Expedited Reports

In my thirty years in this business doing both medical and operational drug safety and pharmacovigilance, I’ve seen that just about every possible permutation of handling expedited reports has been used. In many cases, it does not matter how such reports are handled and most of the different methods work[…]

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FDA Draft Guidance on Rare Diseases

  FDA Draft Guidance: Rare Diseases: Common Issues in Drug Development Guidance for Industry August 2015 In August 2015, the FDA released this new guidance on rare diseases. Its aim is to aid sponsors and manufacturers in the development of drugs and products for rare diseases (defined more or less[…]

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Bart’s Corner: Late Expedited Reports to the FDA

In July, the Journal of the American Medical Association printed a Research Letter and an on-line editorial on pharmaceutical companies’ late expedited (15 day) reports to the FDA. The article (behind a paywall) can be found here. and the editorial here and here. The study is from the University of Minnesota. […]

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Bart’s Corner: In Memoriam Dr. Kelsey

In Memoriam – Frances Kelsey, MD, PhD, 1914-2015 Dr. Kelsey was born in Canada and did her training there and in the US.  After working as a general practitioner, she joined the US FDA as a medical reviewer and ultimately rose to very senior positions. One of her major achievements,[…]

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Compliance, Quality & Cost: Outsourcing Clinical Trial Support

Compliance, Quality & Cost: Why Outsourcing Clinical Trial Support Makes Sense for Start-Up and Mid-Sized Drug Manufacturers Clinical development of a drug or device from discovery through post-marketing approval requires a vast amount of time and resources. During the clinical trial phase, requirements and regulations imposed by governing regulatory bodies[…]

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FDA’s May 2015 Draft Guidance for Investigator Initiated Trials / Studies

Industry expert Bart Cobert reviews the FDA's latest draft guidance for Investigator Intiated Trials & Studies

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Bart’s Corner: FDA’s New REMS Guidance

In April, FDA released a final guidance on Risk Evaluation and Mitigation Strategies (REMS): Modifications & Revisions. The title is a bit of a misnomer. This is not really a modification or revision of the big issues involved with REMS creation and implementation, but rather gives guidance to companies that[…]

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