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Results: 11-20 of 47

FDA issues final rule on sterility testing of biological products

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 11 2012

On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012

Overview and analysis of the proposed federal sunshine

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 30 2012

On December 19, 2011, the Centers for Medicare & Medicaid Services published a proposed rule related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act”

FDA guidance on product name placement in advertising and promotional labeling

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 25 2012

The FDA released a guidance document entitled ‘‘Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling’’ on January 25, 2012

OIG examines how Part D limits drugs to medically-accepted indications

  • Reed Smith LLP
  • -
  • USA
  • -
  • November 29 2011

According to a recent OIG report, “Ensuring That Medicare Part D Reimbursement Is Limited to Drugs Provided for Medically Accepted Indications,” Medicare Prescription Drug Plan sponsors do not have access to information necessary to ensure that Medicare Part D reimbursement is limited to drugs provided for medically-accepted indications (e.g., uses approved by Food and Drug Administration and supported by one or more of three specified compendia

Congressional health policy hearings & markups

  • Reed Smith LLP
  • -
  • USA
  • -
  • November 11 2011

A number of Congressional committees have held hearings recently on health policy issues

Preparing for Round 2 of the DMEPOS competitive bidding program

  • Reed Smith LLP
  • -
  • USA
  • -
  • September 1 2011

As discussed in our August 18, 2011 Special Alert, CMS has announced the product categories and specific competitive bidding areas (CBAs) for Round 2 of the Medicare DME, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program

CMS proposes DME minimum lifetime standard

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 18 2011

As part of the July 8 ESRD PPS proposed rule, CMS included a proposal to revise the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime criterion that must be met by an item or device in order to be considered "durable" for the purpose of classifying the item under the Medicare DME benefit category

GAO issues report on FDA oversight of medical device recalls

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 28 2011

On June 14, 2011, the GAO released a report entitled "Medical Devices: FDA Should Enhance Its Oversight of Recalls."

FDA finalizes Medical Device Data Systems rule

  • Reed Smith LLP
  • -
  • USA
  • -
  • March 7 2011

The FDA has published a final rule reclassifying Medical Device Data Systems (MDDS) as Class I medical devices exempt from 510(k) premarket notification requirements

OIG advisory bulletin on drug manufacturer AMPASP reporting enforcement initiative

  • Reed Smith LLP
  • -
  • USA
  • -
  • September 30 2010

On September 28, 2010, the HHS Office of Inspector General (OIG) issued an Advisory Bulletin that notifies drug manufacturers of an OIG enforcement initiative concerning the timely submission of data under the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, the Federal Upper Limit (FUL) Program, and the Medicare Part B outpatient prescription drug benefit