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Edward M Basile
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Edward M Basile (Ed)
Partner, FDA & Life Sciences Practice Group Leader
WASHINGTON, D.C.
T: +1 202 626 2903
F: +1 202 626 3737
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Profile
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News & Insights
PUBLICATIONS
Results 1-50 of 55
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25 Apr 2012
CLIENT ALERT
FDA Issues Final Guidance Document on Benefit-Risk Determinations
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FDA Issues Two Draft Guidance Documents Related to Investigational Device Exemptions
05 Oct 2011
CLIENT ALERT
FDA Issues Draft Guidance on
De Novo
Classification Process
19 Aug 2011
CLIENT ALERT
FDA Issues Draft Guidance Regarding the Design of Pivotal Clinical Investigations of Medical Devices
09 Aug 2011
CLIENT ALERT
FDA Issues Updated Draft Guidance on Device Modifications
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FDA Issues Draft Guidance on Mobile Medical Apps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FDA Draft Guidance Regarding Financial Disclosures for Clinical Investigators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
24 Mar 2011
CLIENT ALERT
Supreme Court Addresses Securities Law Disclosure Obligations of Pharma/Device Companies
24 Feb 2011
CLIENT ALERT
FDA Issues Rule to Regulate Medical Device Data Systems
22 Feb 2011
CLIENT ALERT
Recent Congressional Activity Presents Opportunity for Medical Device Industry
10 Feb 2011
CLIENT ALERT
FDA Announces Changes Affecting 510(k) Marketing Pathway
04 Jan 2011
CLIENT ALERT
New FDA Informed Consent Requirement Concerning ClinicalTrials.gov Postings
08 Nov 2010
CLIENT ALERT
FDA's Recent Remarks about 510(k) Changes
22 Oct 2010
CLIENT ALERT
Senior FDA Officials Share 510(k) and Enforcement Insights at King & Spalding's Device Summit
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
18 Aug 2010
CLIENT ALERT
FDA and FCC Collaborate on the Regulation of Wireless Healthcare Technologies
02 Aug 2010
CLIENT ALERT
FDA Oversight of Diagnostic Tests
18 Jun 2010
CLIENT ALERT
Summary of the Institute of Medicine’s Second Public Meeting Regarding the 510(k) Process
26 May 2010
CLIENT ALERT
FDA's New Proposals for Expanded Public Disclosure
06 May 2010
CLIENT ALERT
FDA Issues Draft Guidance Documents Regarding FDCA Section 513(g) Requests
05 May 2010
CLIENT ALERT
Important Changes to FDA Expert Panel Review of Premarket Devices
06 Apr 2010
CLIENT ALERT
FDA Issues Direct Final Rule Requiring Submission of Pediatric Use Information for Medical Devices
31 Mar 2010
CLIENT ALERT
Regarding Proposed Rule on DTC Broadcast Drug Ads
31 Mar 2010
CLIENT ALERT
FDA's Proposed Rule Regarding Device Establishment Registration and Listing
25 Mar 2010
CLIENT ALERT
Proposed Rule on Reporting of Data Falsification
09 Mar 2010
CLIENT ALERT
FDA Issues New Guidance Document on Non-Inferiority Clinical Trials
08 Mar 2010
CLIENT ALERT
GAO Report Could Lead to Increased Criminal Prosecutions for Executives
05 Mar 2010
CLIENT ALERT
New Proposed FDA Press Release Template for Recall Announcements
25 Feb 2010
CLIENT ALERT
Senator Grassley Probes Ties Between WebMD and Industry
23 Feb 2010
CLIENT ALERT
FDA Public Meeting on the Center for Devices and Radiological Health’s 510(k) Review Process
16 Feb 2010
CLIENT ALERT
FDA Public Meeting on Incorporating New Science into Regulatory Decision Making
04 Feb 2010
CLIENT ALERT
FDA Announces Public Meeting Regarding 510(k) Review Process
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
19 Jan 2010
NEWSLETTER
Health Headlines
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
01 Jul 2009
ARTICLE
|
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
26 May 2009
CLIENT ALERT
FDA's Outlook under the New Administration
01 Mar 2009
ARTICLE
|
Food and Drug Law Journal
Export of Pharmaceuticals and Medical Devices Under The Federal Food, Drug...
19 Jan 2009
CLIENT ALERT
FDA’s New Guidance on Adverse Event Reporting to Institutional Review Boards in Clinical Trials
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
07 Nov 2007
CLIENT ALERT
FDA Issues New Draft Guidance for Devices Subject to the Tracking Regulation
Results 1-50 of 55
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PRACTICE AREAS
FDA & Life Sciences
Healthcare Industry
MEMBERSHIPS
Order of the Coif
EDUCATION
J.D., George Washington University
B.S.M.E., Lafayette College
ADMISSIONS
U.S. Supreme Court
Washington, D.C.
