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Show: results per page Sort by:  | Summary of FDA Advertising and Promotion Enforcement Activities - November 2012
Scott Cunningham, Scott D. Danzis, Michael S. Labson, Erika Lietzan, Julia F. Post; Covington & Burling LLP;
Legal Alert/Article January 2, 2013, previously published on December 28, 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, biologics, and medical devices.
| | Summary of FDA Advertising and Promotion Enforcement Activities
Scott Cunningham, Scott D. Danzis, Michael S. Labson, Erika Lietzan, Julia F. Post; Covington & Burling LLP;
Legal Alert/Article December 6, 2012, previously published on December 3, 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, biologics, and medical devices.
| | Summary of FDA Advertising and Promotion Enforcement Activities
Scott Cunningham, Scott D. Danzis, Michael S. Labson, Erika Lietzan, Julia F. Post; Covington & Burling LLP;
Legal Alert/Article November 2, 2012, previously published on October 31, 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, biologics, and medical devices. In September 2012, FDA’s Office of Prescription Drug...
| | Summary of FDA Advertising and Promotion Enforcement Activities - July 2012
Scott Cunningham, Scott D. Danzis, Michael S. Labson, Erika Lietzan, Julia F. Post; Covington & Burling LLP;
Legal Alert/Article September 5, 2012, previously published on August 31, 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, biologics, and medical devices. In July 2012, FDA’s Office of Prescription Drug...
| | Summary of FDA Advertising and Promotion Enforcement Activities
Scott Cunningham, Scott D. Danzis, Michael S. Labson, Erika Lietzan, Julia Post; Covington & Burling LLP;
Legal Alert/Article August 2, 2012, previously published on July 26, 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, biologics, and medical devices. In June 2012, FDA’s Office of Prescription Drug...
| | Summary of FDA Advertising and Promotion Enforcement Activities - May 2012
Scott Cunningham, Scott D. Danzis, Michael S. Labson, Erika Lietzan, Julia Post; Covington & Burling LLP;
Legal Alert/Article June 12, 2012, previously published on June 11, 2012 This e-alert is part of a series of monthly e-alerts summarizing publicly-available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of drugs, biologics, and medical devices. In May 2012, FDA’s Office of Prescription Drug Promotion...
| | CMS Delays Physician Payments Sunshine Act Data Collection Requirement
Stefanie A. Doebler, Amalia Fenton, Anna D. Kraus, Erika Lietzan; Covington & Burling LLP;
Legal Alert/Article May 8, 2012, previously published on May 7, 2012 On May 3, 2012, the Centers for Medicare & Medicaid Services (CMS) posted on its official blog a statement delaying enforcement of the requirement that applicable manufacturers of drugs, devices, biologicals, or medical supplies for which coverage is available under Medicare, Medicaid, or the...
| | FDA Releases Draft Guidance on Responding to Unsolicited Requests for Off-Label Information and Seeks Stakeholder Input on Scientific Exchange
Afia K. Asamoah, Scott Cunningham, Scott D. Danzis, Michael S. Labson, Erika Lietzan; Covington & Burling LLP;
Legal Alert/Article January 18, 2012, previously published on January 9, 2012 On December 30, 2011, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” The draft guidance...
| | CMS Issues Proposed Rule Implementing Sunshine Act: Review, Correction, and Publication of Data on Public Website
Stefanie A. Doebler, Amalia Fenton, Demetrios L. Kouzoukas, Anna D. Kraus, Erika Lietzan; Covington & Burling LLP;
Legal Alert/Article January 2, 2012, previously published on December 30, 2011 On December 19, 2011, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule implementing Section 6002 of the Affordable Care Act (ACA) (Pub. L. 111-148, as amended by Pub. L. 111-152), which requires applicable manufacturers and group purchasing organizations (GPOs) to...
| | CMS Issues Proposed Rule Implementing Sunshine Act
Stefanie A. Doebler, Amalia Fenton, Demetrios L. Kouzoukas, Anna D. Kraus, Erika Lietzan; Covington & Burling LLP;
Legal Alert/Article December 26, 2011, previously published on December 23, 2011 On December 19, 2011, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule implementing Section 6002 of the Affordable Care Act (ACA) (Pub. L. 111-148, as amended by Pub. L. 111-152), which requires applicable manufacturers and group purchasing organizations (GPOs) to...
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