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12/31/2008
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Health Policy and Regulatory Affairs Newsletter, December 2008
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12/29/2008
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NRC Announces Teleconference Meeting of the ACMUI on January 22, 2009
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12/9/2008
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AHRQ Schedules a Patient Safety Organization Update Conference Call
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12/5/2008
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NRC Announces Teleconference Meeting of the ACMUI on December 18, 2008
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11/26/2008
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Health Policy and Regulatory Affairs Newsletter, November 2008
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11/25/2008
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CMS Issues 2009 Final Medicare Physician Fee Schedule (MPFS) Rule
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11/21/2008
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AHRQ Publishes Final Rule Implementing the Patient Safety Act
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11/5/2008
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AHRQ Begins Listing PSOs
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10/31/2008
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Health Policy and Regulatory Affairs Newsletter, October 2008
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10/21/2008
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Joint Society PET NCA Comment Letter Sent to CMS
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10/17/2008
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SNM Posts Survey for Information Relating to the Current Shortage of Mo-99
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10/14/2008
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AHRQ Issues Interim Guidance: "Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization"
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10/9/2008
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NIH Requests Comments on Information Program on Clinical Trials: Maintaining a Registry and Results Databank
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10/9/2008
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FDA Requests Comments on Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
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10/8/2008
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FDA Issues Draft Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products
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10/8/2008
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Covidien Continues to Update Customers on Mo-99 Shortage
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10/6/2008
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NRC Extends Comment Period for Proposed Rule on Medical Use of Byproduct Material—Amendments/Medical Event Definitions
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10/3/2008
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SNM Submits Comments to the NRC Regarding Medical Use of Byproduct Material—Amendments/Medical Event Definitions
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10/1/2008
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NRC Assumes Regulatory Authority Over Certain Radioactive Materials In Five States and U.S. Territories
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10/1/2008
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FDA Announces Public of Web Location of 2009 Proposed Guidance Development for CDRH
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9/30/2008
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Health Policy and Regulatory Affairs Newsletter, September 2008
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9/26/2008
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NRC Grants Extension of Comment Period for the Security and Continued Use of Cesium-137 Chloride Sources
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9/25/2008
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NRC Issues Regulatory Guide 10.9 (Revision 2): "Guide for the Preparation of Applications for the Use of Self-Contained Dry Source-Storage Gamma Irradiators"
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9/25/2008
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NRC Issues Regulatory Guide 10.7 (Revision 2): "Guide for the Preparation of Applications for Licenses for Laboratory and Industrial Use of Small Quantities of Byproduct Material"
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9/24/2008
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SNM Files Comments to NRC Regarding Natural Resources Defense Council Petition for Rulemaking
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9/22/2008
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ACMUI Announces October 27-28 Meeting
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9/16/2008
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NRC Issues Regulatory Guide 10.8 (Revision 3): "Guide for the Preparation of Applications for Medical Use Programs"
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9/16/2008
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NRC Further Revises Licensing Guidance for Therasphere and SIRSpheres Yttrium-90 Microspheres
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9/15/2008
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GE Healthcare Continues to Update its Customers Regarding Shortage of Medical Isotopes
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9/11/2008
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Covidien Sends Follow-up Customer Letter Regarding Shortage of Medical Isotopes
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9/10/2008
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NRC Announces New Members to the Advisory Committee on Medical Uses of Isotopes
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9/10/2008
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Lantheus Sends Customer Letter Regarding Shortage of Medical Isotopes
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9/8/2008
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FDA Announces Public Workshop on FDA Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice
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9/8/2008
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GE Healthcare Sends Follow-up Customer Letter Regarding Shortage of Medical Isotopes
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9/4/2008
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NRC ACMUI Calls for Nominations
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9/3/2008
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GE Healthcare Sends Customer Letter Regarding Shortage of Medical Isotopes
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9/2/2008
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Advisory Panel (MedCAC) Meets to Review Evidence to Expand PET Coverage for Oncology Indications – Results Posted
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8/29/2008
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Health Policy and Regulatory Affairs Newsletter, August 2008
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8/28/2008
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Covidien Sends Customer Letter Regarding Shortage of Medical Isotopes
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8/27/2008
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SNM Expresses Serious Concerns as Isotope Shortage Looms
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8/25/2008
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NRC Extends Comment Period on a Petition for Rulemaking Filed by the Natural Resources Defense Council
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8/25/2008
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NRC Revises Licensing Guidance for Therasphere and SIRSpheres Yttrium-90 Microspheres
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8/6/2008
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NRC Issues Proposed Rule Regarding Medical Use of Byproduct Material—Amendments/Medical Event Definitions
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8/6/2008
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FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
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7/31/2008
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The NRC Seeks Comments on the Security and Continued Use of Cesium-137 Chloride Sources and Announces a Public Meeting
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7/31/2008
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Health Policy and Regulatory Affairs Newsletter, July 2008
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7/30/2008
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Have You Been Selected to Participate in the Physician Practice Information Survey?
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7/23/2008
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NRC Issues Regulatory Issue Summary: Voluntary Security Enhancements for Self-Contained Irradiators Containing Cesium Chloride Sources
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7/21/2008
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NRC Issues Regulatory Guide 6.2 (Revision 2): "Integrity and Test Specifications for Selected Brachytherapy Sources"
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7/18/2008
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FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
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7/15/2008
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FDA Releases Public Health Notification: Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning
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7/15/2008
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FDA Releases Final Rule on Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials
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7/10/2008
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Senate Passes Medicare Bill
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7/9/2008
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MDS Commences Arbitration against AECL over Cancelled MAPLE Project and Files $1.6 Billion Court Claim against AECL and the Government of Canada
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6/30/2008
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Health Policy and Regulatory Affairs Newsletter, June 2008
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6/26/2008
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NRC Issues Regulatory Issue Summary Regarding Dose Limit for Patient Release Under 10 CFR 35.75
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6/26/2008
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SNM Isotope Availability Task Group Releases Preliminary Draft Report
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6/24/2008
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The Civil Aviation Administration of China Allows Transport of Medical Isotopes During 2008 Olympic Games
|
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6/24/2008
|
Colorado Department of Public Health & Environment Issues Security Initiatives for Democratic National Convention
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6/11/2008
|
Bush Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety
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6/6/2008
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NRC Publishes Final Rule for the Revision of Fee Schedules and Fee Recovery for Fiscal Year 2008
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6/2/2008
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ACMUI Announces July 21, 2008 Teleconference to Discuss 10 CFR Part 35 Rulemaking on Permanent Implant Brachytherapy and Ritenour Petition for Rulemaking
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5/30/2008
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Health Policy and Regulatory Affairs Newsletter, May 2008
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5/27/2008
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NRDC Petitions the NRC for Rulemaking Regarding Licensing the Use or Export of Highly Enriched Uranium
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5/22/2008
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SNM Explores Feasibility of U.S. Medical Isotope Source
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5/21/2008
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NRC Denies Crane Petition
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5/19/2008
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AECL Discontinues Development of Isotope Reactors
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5/19/2008
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NRC Issues New Guidance on Release on Thyroid Patients Administered Radioactive Iodine
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4/30/2008
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Health Policy and Regulatory Affairs Newsletter, April 2008
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4/23/2008
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AHRQ Requests Nominations for Public Members of the National Advisory Council for Healthcare Research and Quality
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4/22/2008
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FDA Issues Draft Guidance: Certifications to Accompany Drug, Biological Product and Device Applications/Submissions
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4/11/2008
|
NRC Proposes Expansion of National Source Tracking System
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4/10/2008
|
CMS opens reconsideration of the NCD on Positron Emission Tomography (PET) (CAG-00181R)
|
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3/31/2008
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Pennsylvania Becomes 35th Agreement State
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3/31/2008
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Health Policy and Regulatory Affairs Newsletter, March 2008
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3/28/2008
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Commissioner Kristine Svinicki Takes Oath of Office at NRC
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3/28/2008
|
NRC Submits Corrections to Fee Schedules
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|
3/25/2008
|
NOPR Study Released: Confirms FDG-PET Has Major Impact on Management of Cancer Patient Care
|
|
3/21/2008
|
NRC Announces Renewal of the Advisory Committee on the Medical Uses of Isotopes
|
|
3/19/2008
|
Independent External Review Panel Recommends Changes to NRC's Materials Licensing Process
|
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3/18/2008
|
NRC Announces April 28-29, 2008 ACMUI Meeting
|
|
3/17/2008
|
The current issue of NRC Update features comments made in response to the NRC's proposed rulemaking regarding "Medical Use of Byproduct Material—Amendments/Medical Event Definitions"; comments submitted by SNM are featured prominently
|
|
3/14/2008
|
US Senate confirms Kristine Svinicki as an NRC Commissioner
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3/14/2008
|
CARE Bill Passed in Senate HELP Committee
|
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3/5/2008
|
FDA Releases Guidance for Industry and FDA Staff on Expedited Review of Premarket Submissions for Devices
|
|
3/5/2008
|
NRC Announces Briefing by Independent External Panel to Identify Vulnerabilities in the US NRC's Materials Licensing Program
|
|
3/5/2008
|
SNM Thanks Congress for Restoring Nuclear Medicine Funding
|
|
3/3/2008
|
SNM Submits Comments to NRC on Advanced Notice of Proposed Rulemaking Regarding "Medical Use of Byproduct Material—Amendments/Medical Event Definitions"
|
|
3/1/2008
|
Health Policy and Regulatory Affairs Newsletter, February 2008
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|
2/29/2008
|
FDA Releases Guidance for Industry and FDA Staff on Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs and BLA Supplements
|
|
2/25/2008
|
FDA Releases "Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."
|
|
2/21/2008
|
The National Academies Releases Report Encouraging the Government to Spur Replacement of Radioactive Cesium Chloride in Medical and Research Equipment
|
|
2/19/2008
|
NRC Announces March meeting of the Independent External Review Panel to Identify Vulnerabilities in the US Nuclear Regulatory Commission's Materials Licensing Program
|
|
2/19/2008
|
NRC Announces Completion of NUREG-1556, Volume 9, Revision 2, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses"
|
|
2/13/2008
|
Nuclear Regulatory Commission (NRC) Submits Proposed Rules Regarding Revision of Fee Schedules and Fee Recovery for FY 2008
|
|
2/13/2008
|
Agency for Healthcare Research and Quality (AHRQ) releases its proposed regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005
|
|
2/8/2008
|
Senate Markup of CARE Bill Scheduled for February 14
|
|
2/8/2008
|
DOE FY 2009 Budget Includes Funding for Basic Research
|
|
2/8/2008
|
March Meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee to Discuss Computer Aided Detection and Diagnosis Devices for Radiological Images
|
|
2/1/2008
|
Health Policy and Regulatory Affairs Newsletter, January 2008
|
|
1/28/2008
|
Covidien Post Quality Assurance Issue Involving Molybdenum-99
|
|
1/28/2008
|
Action Alert: CARE Legislation
|
|
1/16/2008
|
Canadian Nuclear Safety Commission President Stripped of Position
|
|
1/16/2008
|
Action Alert: Thank Congress for Restoring Nuclear Medicine Funding
|
|
1/15/2008
|
NRC Announces Expanded Photo Gallery On Its Web Site
|
|
1/11/2008
|
NRC Releases RIS 2007- 28, Security Requirements for Portable Gauges
|
|
1/10/2008
|
NRC Issues Information Notice 2007-38, Ensuring Complete and Accurate Information in the Documentation of Training and Experience for Individuals Seeking Approval as Medical Authorized Users
|
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1/1/2008
|
Health Policy and Regulatory Affairs Newsletter, December 2007
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