Food and Drug Administration Safety and Innovation Act

News & Analysis as of

FDA seeking comments on Health IT report

Exchange of information in an electronic environment (health IT) has provided and continues to provide opportunities to improve the quality, safety, cost and efficiency of health care and encourage patient involvement. ...more

Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

FDA Releases FDASIA Health IT Report

On April 3, 2014, the Food and Drug Administration (FDA) released the FDASIA Health IT Report (Report). This Report fulfills Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

The FDASIA Health IT Report

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

The FDA’s Latest One-Two Punch to Combat Drug Shortages

On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more

FDA Issues Final Guidance on Mobile Medical Apps: “De-Regulatory” Move Helps Clarify Certain Key Questions, But Leaves Others Open

On September 25, 2013, the Food and Drug Administration (FDA) issued its long-awaited final guidance on health-related software applications intended for use on mobile devices. Under the guidance, FDA will regulate only those...more

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more

Request for Comments on Risk-Based Regulatory Framework for Health IT

An interagency working group – composed of the Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC) – is seeking...more

FDA Regulatory Update: FDA Commissioner Suggests that New LDT Regulations are Forthcoming; Laboratory Industry Challenges FDA’s...

On June 2, 2013, U.S. Food and Drug Administration (“FDA”) Commissioner Margaret Hamburg delivered a speech at the American Society of Clinical Oncology’s annual meeting, in which she explained that the FDA is in the process...more

FDA Regulatory Update: Laboratory-Developed Tests Once Again Come Under FDA’s Microscope and Laboratory Industry Opposes

Laboratory-developed tests (“LDTs”) appear to be under FDA’s microscope once again. These tests, which include genetic tests, companion diagnostics, and genetic tests, are developed and performed by a laboratory and have been...more

Agencies Seek Comments to Inform Future Health IT Regulation

As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more

FDA Issues Final Guidance Documents on FDA’s eCopy Program for Medical Device Submissions

On December 31, 2012, FDA issued a final guidance document entitled “eCopy Program for Medical Device Submissions” (“eCopy guidance”). Section 745A(b) of the Federal Food, Drug, and Cosmetic (FDC) Act, which was added by...more

FDA to Finalize Mobile Medical App Rules Following Bill Passage

Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of...more

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