Life Science Compliance Update

March

2017

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A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the outgoing Obama Administration issued a litany of final and draft guidances in a roughly six-week period. This article briefly reviews these new guidance documents.

October

2016

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June

2016

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The Dreaded Performance Appraisal – How the FDA Is Doing with Medical Devices and the Medical Device Industry

Written by , Posted in Abstract, FDA

Calisha D. Myers, Esq., Staff Writer for Life Science Compliance Update

The FDA and the GAO both released data on the FDA’s performance in medical device regulation over the last several years. This article takes a close look at this data and compares it with the data available through the FDA’s OpenFDA database. The data shows recalls have increased, but postmarket and postapproval studies have declined.

May

2016

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Smoking It – FDA Proposes Changes to Adequate Labeling Provision in a Tobacco Regulation

Written by , Posted in Abstract, FDA

Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update
The FDA has proposed changes to “adequate labeling” provisions for drugs and devices. This article sheds light on the proposed change, as well as the potential impact if the proposed rule becomes finalized.

March

2016

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Exploring Strange New Worlds – FDA’s 2016 Program Alignment and Strategic Priorities

Written by , Posted in Abstract, FDA

By: Calisha D. Myers, Esq., Staff Writer – Life Science Compliance Update

This article provides an overview of the FDA’s initiative to realign programs from location-centered structures and specializations to commodities specializations, and its impact on the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA).

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