Thursday, October 23, 2014

Federal Register | FDA Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

Federal Register | Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability:

"FDA is announcing the availability of a guidance for industry entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” On July 9, 2012, FDASIA (Pub. L. 112-144) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C Act to make a drug adulterated that “has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” As required by Section 707, FDA is issuing this guidance to define the types of action, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of Section 501(j) of the FD&C Act."

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Read the FDA Final Guidance:
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (PDF - 106KB)

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Thursday, October 2, 2014

Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov

Read the full article: Reports > FDA Strategic Priorities: 2014 - 2018 - FDA.gov:

"This Strategic Priorities document articulates the goals and priorities that guide our Agency. It creates a framework that will allow us to integrate and achieve our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.

While the priorities are individually important, they are also interconnected and cannot be addressed in isolation. Thus, for example, regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities. The cross-cutting nature of this plan will help FDA achieve the greatest benefits.

This document also sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to – and making better informed decisions about – the products FDA regulates. It describes in detail key strategies to help the Agency fulfill its public health mission."

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Download the document:  FDA Strategic Priorities 2014-2018 (pdf)

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Wednesday, October 1, 2014

The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov

Read the full press release:  Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:

"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."

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