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Focus on Regulation

Tag Archives: FDASIA

First Custom Device Annual Report Due March 31, 2015

On September 24, the Food and Drug Administration (FDA) released a final guidance document clarifying the revised custom device exemption implemented in Section 520(b) of the Food, Drug, and Cosmetic Act (FDCA) by the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. [1]/ The final guidance provides helpful clarification of various elements of

FDA Issues Two Proposed Guidance Documents For Laboratory Developed Tests

On July 31, 2014, FDA provided Congress advance copies of two proposed guidance documents regarding Laboratory Developed Tests (LDTs), which the Agency had planned to issue 60 days later.  The first is titled FDA Notification and Medical Device Reporting for Laboratory Developed Tests; the second is Framework for Regulatory Oversight of Laboratory Developed Tests.  (A

FDA Proposes Enforcement Discretion for Medical Device Data Systems, Medical Image Storage Solutions, and Medical Image Communications Devices

In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would refrain from enforcement of all regulatory requirements for a subset of hardware and software that transfers, stores, converts, formats, and displays medical device data or medical imaging data, which would

FDA Health IT Initiatives: OpenFDA and FDASIA Health IT Public Workshop

In the last month, the Food and Drug Administration (FDA) undertook two new steps related to Health IT in the United States While the FDA’s involvement in this area of technology remains very controversial, both projects sought to enhance collaboration with the Health IT industry. FDASIA Workshop First, on May 13-15, 2014, the FDA, Federal Communications Commission (FCC),

FDA Health IT Initiatives: OpenFDA and FDASIA Health IT Public Workshop

In the last month, the Food and Drug Administration (FDA) undertook two new steps related to Health IT in the United States While the FDA’s involvement in this area of technology remains very controversial, both projects sought to enhance collaboration with the Health IT industry. Read More: FDA Health IT Initiatives: OpenFDA and FDASIA Health

FDA Issues Proposed Rule to Implement Its New Authority to Destroy Drugs Valued at $2,500 or Less That Are Refused Import Into the U.S.

On May 6, 2014, FDA issued a proposed rule to implement the agency’s new administrative authority to destroy drugs valued at $2,500 or less that have been refused admission during importation into the United States1. FDA is requesting that interested parties submit comments on the proposed rule by July 7, 2014. FDA developed the proposed

The First Drug with a Breakthrough Therapy Designation Receives FDA Approval

On November 1, 2013, the Food and Drug administration (FDA) approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).  CLL is a blood and bone marrow cancer that usually has a slow progression compared to other types of leukemia.  According to the National Cancer Institute,

President signs The Food and Drug Administration Safety and Innovation Act: Summary of certain key provisions

President Obama recently signed into law The Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA will reauthorize for another five years the Prescription Drug User Fee Act (PDUFA V) and the various related user fee agreements between the drug and device industries and FDA. FDASIA includes provisions related to drugs, devices, generic drugs,

Congress Clarifies the Custom Device Exemption, But Questions Remain

Congress has passed The Food and Drug Administration Safety and Innovation Act (FDASIA) reauthorizing existing FDA user fee programs and extending these programs to generic drugs and biosimilars, which is now headed to the President’s desk to be signed into law. In addition to authorizing user fee programs that are expected to cover 60% of the agency’s 2013‒2017