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On August 22, 2014, the Drug Enforcement Administration (DEA) published a final rule upscheduling hydrocodone combination products (HCPs) under the Controlled Substances Act (CSA) from Schedule III to Schedule II.
On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more
Laboratory Developed Tests -
After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress...more
On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing their concerns regarding the naming of biosimilar products in light of the...more
On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices.
On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more
In Center for Biological Diversity v. Environmental Protection Agency, No. 11-cv-00293-JCS, plaintiffs alleged that the Environmental Protection Agency (EPA) violated section 7 of the Endangered Species Act by failing to...more
On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...more
Within several months of Securities and Exchange Commission Chair Mary Jo White’s announcement in late 2013 of a commitment to improving the SEC’s trial readiness, the Commission suffered a number of losses in federal...more
In This Issue:
- Stakeholders Urge FDA to Provide Clarity on Biosimilars
- Ebola Crisis Continues
- Implementation of the Affordable Care Act
- Other Federal Regulatory Initiatives
The U.S. Food and Drug Administration (“FDA”) has released its latest “Guidance for Industry” regarding the FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which established an...more
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
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
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
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
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
In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more
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
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
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
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
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
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
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
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
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