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Health Care Update - August 2014 #3

In This Issue: - Stakeholders Urge FDA to Provide Clarity on Biosimilars - Ebola Crisis Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

FDA Releases Another Prospective Guidance

On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more

FDA Takes First Steps Towards Regulating Laboratory Developed Tests

On July 31, the Food and Drug Administration (FDA or “the Agency”) notified Congress that it intends to issue draft guidance proposing a Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (“Draft...more

ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,...more

FDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings

On July 23, 2014, the Food and Drug Administration (FDA) issued its response to two citizen petitions submitted by AbbVie Inc. (AbbVie) and Auxilium Pharmaceuticals, Inc. (Auxilium) requesting that FDA initiate...more

FDA Releases Long-Awaited LDT Regulatory Framework and Finalizes Companion Diagnostics Guidance

On July 31, 2014, the Food and Drug Administration (FDA) took several significant actions to clarify its policies regarding regulation of certain in vitro diagnostic devices (IVDs). First, FDA released its long-awaited plan...more

OIG Finds Privacy and Security Risks with ONC EHR Certification Process

It is ironic to learn the Office of Inspector General (OIG) believes the Office of the National Coordinator for Health Information Technology (ONC) essentially has an insufficient compliance program to maintain the privacy...more

Anticipated Framework for Regulatory Oversight of Laboratory Developed Tests

Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory developed tests (LDTs) and has not required laboratories that furnish LDTs to comply with FDA’s...more

FDA Issues Notice to Congress of Its Intent to Comprehensively Regulate Laboratory Developed Tests (LDTs)

On July 31, 2014, the U.S. Food and Drug Administration (FDA) "pre-published" its proposed new plan to regulate laboratory developed tests (LDTs). In letters to the U.S. Senate and the House of Representatives, the FDA...more

Medical Device Update: FDA Issues Final Guidance on 510(k) Determinations, Use of “Split” Predicates Strongly Discouraged

On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more

FDA Issues Final Guidance on Evaluating Substantial Equivalence in 510(k) Submissions

On July 28, 2014, the Food and Drug Administration (“FDA”) issued final guidance regarding the agency’s substantive review of Traditional 510(k) premarket notifications. This document, titled “The 510(k) Program: Evaluating...more

FDA Releases Draft Guidance To Help Determine Substantial Equivalence for a Device that Has Different Technological...

In a new Draft Guidance entitled, Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics, (the “Draft Guidance”) released on...more

FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S....more

FDA Issues Updated Draft Guidance on Reporting Drug Samples

The guidance calls for 2014 reporting by April 1, 2015. When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...more

Guidance Helps Medical Device Companies Determine Substantial Equivalence

When is a medical device substantially equivalent to another device? Like so much else, it depends. On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance that aims to clarify that question....more

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

FDA Issues 510(k)/Substantial Equivalence Draft Guidance Describes Benefit-Risk Factors Considered for New 510(k) Devices with...

On July 15, 2014, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance document titled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)]with Different...more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Health Update - July 2014

Avoiding the Regulatory Land Mines of Commercial ACOs - While providers are showing great interest in creating ACOs to participate in the Medicare Shared Savings Program (MSSP), they are showing even greater enthusiasm...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

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