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Beverly H Lorell MD
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Beverly H Lorell MD (Bev)
Consultant
WASHINGTON, D.C.
T: +1 202 383 8937
F: +1 202 626 3737
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Profile
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News & Insights
PUBLICATIONS
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04 Jan 2012
CLIENT ALERT
Responding to Unsolicited Requests for Off-Label Information
17 Nov 2011
CLIENT ALERT
FDA Issues Two Draft Guidance Documents Related to Investigational Device Exemptions
07 Sep 2011
CLIENT ALERT
HHS Final Rule Regarding Investigator Financial Interests
06 Sep 2011
ARTICLE
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HCCA/AHLA Fraud & Compliance Forum
Clear As Mud: CMS Coverage Requirements for Implantable Defibrillators
19 Aug 2011
CLIENT ALERT
FDA Issues Draft Guidance Regarding the Design of Pivotal Clinical Investigations of Medical Devices
25 Jul 2011
CLIENT ALERT
FDA Issues Draft Guidance on Mobile Medical Apps
06 Jun 2011
NEWSLETTER
Health Headlines - June 6, 2011
01 Jun 2011
CLIENT ALERT
FDA Draft Guidance Regarding Financial Disclosures for Clinical Investigators
20 Apr 2011
CLIENT ALERT
FDA Issues Draft Charter for CDRH Center Science Council
28 Feb 2011
NEWSLETTER
Health Headlines
24 Feb 2011
CLIENT ALERT
FDA Issues Rule to Regulate Medical Device Data Systems
10 Feb 2011
CLIENT ALERT
FDA Announces Changes Affecting 510(k) Marketing Pathway
31 Jan 2011
CLIENT ALERT
HHS OIG Recommends New Federal Regulations to Govern NIH Grantee Institutions
04 Jan 2011
CLIENT ALERT
New FDA Informed Consent Requirement Concerning ClinicalTrials.gov Postings
01 Jan 2011
ARTICLE
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Dennis Barry's Reimbursement Advisor
CMS Coverage Criteria for Implantable Cardiac Defibrillators
08 Nov 2010
CLIENT ALERT
FDA's Recent Remarks about 510(k) Changes
22 Oct 2010
CLIENT ALERT
FDA Issues Final Rule on IND Safety Reporting
27 Sep 2010
CLIENT ALERT
FDA and CMS Consider Parallel Review of Medical Products
31 Aug 2010
CLIENT ALERT
FDA's Preliminary Reports Regarding 510(k) Changes and New Science
07 Jun 2010
CLIENT ALERT
New Proposed Amendments to DHHS Requirements for Investigator Disclosures
26 May 2010
CLIENT ALERT
FDA's New Proposals for Expanded Public Disclosure
18 May 2010
CLIENT ALERT
FDA’s New “Bad Ad” Program Asks Physicians to Watch for Improper Promotion
01 May 2010
ARTICLE
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Med Ad News
Clear, Conspicuous, and Neutral
27 Apr 2010
CLIENT ALERT
Council of Medical Specialty Societies Issues Code for Interactions with the Life Sciences Industry
31 Mar 2010
CLIENT ALERT
Regarding Proposed Rule on DTC Broadcast Drug Ads
25 Mar 2010
CLIENT ALERT
Proposed Rule on Reporting of Data Falsification
24 Mar 2010
CLIENT ALERT
Passage of Health Care Reform: Key Provisions Impacting Manufacturers of Pharmaceuticals, Biologics and Devices
09 Mar 2010
CLIENT ALERT
FDA Issues New Guidance Document on Non-Inferiority Clinical Trials
05 Mar 2010
CLIENT ALERT
New Proposed FDA Press Release Template for Recall Announcements
25 Jan 2010
CLIENT ALERT
FDA’s New Draft Guidance Greatly Expands Recommendations for IRB Continuing Reviews
25 Jan 2010
CLIENT ALERT
FDA Proposes New Rule for Informed Consent
06 Nov 2009
CLIENT ALERT
FDA Holds Second Transparency Task Force Public Meeting
06 Nov 2009
CLIENT ALERT
Clinical Investigator Responsibilities – Protecting the Rights, Safety and Welfare of Study Subjects
10 Jul 2009
CLIENT ALERT
Clinical Trial Registration and Results Disclosure
01 Jul 2009
ARTICLE
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The Metropolitan Corporate Counsel
FDA's New Transparency Task Force: Mission And Opportunity For Public Comment
22 Jun 2009
CLIENT ALERT
Subcommittee on Health Examines Medical Device Safety
12 Jun 2009
CLIENT ALERT
FDA’s New Transparency Task Force: Mission and Opportunity for Public Comment
09 Feb 2009
CLIENT ALERT
Clinical Trial Registration and Results Disclosure
28 Jan 2009
CLIENT ALERT
Grassley, Kohl Introduce Physician Payments Disclosure Law
19 Jan 2009
CLIENT ALERT
FDA’s New Guidance on Adverse Event Reporting to Institutional Review Boards in Clinical Trials
14 Jan 2009
CLIENT ALERT
FDA Issues Final Guidance for Dissemination of Off-Label Reprints
06 Aug 2008
CLIENT ALERT
FDA Announces Major Policy Changes Regarding Conflict of Interest Management & Conduct of Advisory Committees
01 Aug 2008
CLIENT ALERT
CMS Seeks to Restrict Coverage Through New National Coverage Determinations
10 Jun 2008
CLIENT ALERT
FDA Issues Proposed Rule on Pregnancy and Lactation Labeling
18 Dec 2007
CLIENT ALERT
December 26, 2007 Deadline for Registration of "Applicable Clinical Trials" and New Certification Requirement
04 Dec 2007
CLIENT ALERT
Potential for New Federal Device Price Reporting Requirements
20 Jul 2007
CLIENT ALERT
CMS Releases New Proposed Decision Memo on Clinical Trial Policy
19 Jul 2007
CLIENT ALERT
CMS Establishes New Payment Methodology for Ambulatory Surgical Centers
11 Jul 2007
CLIENT ALERT
CMS Issues Decision Memorandum for Clinical Trial Policy (CAG-0071R) Many Issues Left Unresolved
06 Jul 2007
CLIENT ALERT
CMS Releases Physician Fee Schedule Proposed Rule
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PRACTICE AREAS
FDA & Life Sciences
Clinical Research Compliance
Health Government Advocacy
Healthcare Reimbursement
EDUCATION
B.A., Stanford University
M.D., Stanford University
