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Melissa Gilmore

Senior Counsel

Related Content

Practices
Industries
International
Education
  • Georgetown University Law Center, JD, cum laude, Senior Staff Editor, Georgetown Journal of Legal Ethics, 1996
  • Duke University, AB, 1991
  • Duke University, The Fuqua School of Business, Certificate, Markets and Management Studies, 1991
Admissions
  • New York
  • District of Columbia
  • California
  • Washington
Affiliations

Member, American Bar Association

Member, District of Columbia Bar Association

Member, Women's Bar Association

Membership Committee, Women’s Bar Association of the District of Columbia 

Languages
  • German
  • French
Print

Melissa heads McGuireWoods' FDA practice, focusing on FDA regulatory and compliance issues for medical device, drug, biotech, food, dietary supplement, and tobacco companies.

She partners with her clients to shepherd their products through FDA and maintain ongoing compliance throughout the product life cycle - from development through clearance/approval, launch, commercialization, and quality management. Melissa achieves the most effective and efficient results for her clients by using the ultimate goal to define her strategy, and by working collaboratively with her strong contact network at FDA.

In her day-to-day practice, Melissa provides medical device manufacturers and other health sciences companies with comprehensive, strategic regulatory guidance and preventative liability consulting. She also uses her significant product litigation background to provide a unique, value-added approach to mitigate her clients' regulatory, litigation, and product liability risks. Additionally, Melissa performs due diligence audits for companies interested in financial transactions with regulated health sciences businesses.

Melissa is an active member of the life sciences community. She speaks around the country and writes regularly about developing issues within FDA. She also publishes a weekly Life Sciences NewsBrief to a worldwide readership. Prior to joining McGuireWoods, Melissa was the founder and principal of an FDA regulatory boutique law firm.

vCard
T: +1 202 857 1724F: +1 202 828 3302mgilmore@mcguirewoods.com2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

Work collaboratively with FDA and clients to navigate regulatory pathways for 510(k), PMA, IDE, NDA, ANDA, and IND submissions as well as ongoing amendments and supplements.

Perform comprehensive regulatory risk and strategy assessments, gap analyses, benchmarking, compliance program analysis, and other core FDA analyses.

Provide counsel on off-label issues, including advertising, marketing, promotion, and labeling of FDA-regulated products and the FTC overlay. Provide support on related regulatory aspects of Lanham Act and False Claims Act litigation.

Conduct targeted competitor compliance surveillance programs, incorporating FOIA and Office of Compliance tools.

Guide manufacturers through Orphan Product and Expanded Access Programs (Humanitarian, Individual, and Emergency Use).

Provide counsel on new technology regulations and policies, including mobile medical apps, wireless networks, HIPAA, and EHR.

Advise on compliance with post-marketing and surveillance requirements, including adverse event reporting, patient registries, medical device reporting, periodic reporting, post-market studies.

Participate in manufacturing compliance activities including quality, recordkeeping, audits and inspections, GMP issues, CAPA, EIRs, Warning Letters, corrective action plans, and 483 response activities.

Advocate on health policy issues, most recently mHealth, User Fee exemptions, and the Medical Device Tax.

Perform regulatory due diligence audits for companies interested in financial transactions with regulated healthcare businesses.

Provide regulatory expertise and support for litigation involving FDA-regulated products and companies.

Counsel FDA-regulated clients on avoiding and responding to FDA/DOJ investigations.

Co-author, "Reform Brings Big Changes to Life Sciences Sector," The National Law Journal, July 26, 2012
Co-author, "FDA Unveils 25 Initial 510(k) Changes, Refers Controversial Recommendations to the Institute of Medicine," Health Care Law Monthly, June 2011
Co-author, "Brave New FDA," American Health Lawyers Association Magazine, April 2010
Speaker, "Navigating the Premarket Approval Process (PMA)," American Conference Institute's Second Annual FDA Boot Camp Devices Edition, October 24, 2012
Speaker, 2nd Annual Pharmaceutical & Biotechnology Manufacturing Forum, May 6-8, 2012
Speaker, Quality Assurance in Pharmaceutical Manufacturing Conference, October 3-4, 2011
Speaker, "FDA Marketing Approval/Clearance Pathway Reform and the Potential Implications for Parallel Review," Washington, D.C., September 2011
Speaker, "FDA Marketing Approval/Clearance Pathway Reform and the Potential Implications for Parallel Review," Fraud and Abuse Conference, September 12, 2011
Speaker, "FDA's New 510(k) Plan of Action - Overview, Trigger Points, and Analysis," Life Sciences Quarterly Lunch Break, May 18, 2011
Speaker, "510(k) Plan of Action: Overview, Trigger Points, Analysis," McGuireWoods Webinar, February 10, 2011
Speaker, "FDA Unveils 25 Initial 510(k) Changes, Refers Controversial Recommendations to Institute of Medicine," NCBIO Medical Device Forum - Regulatory & Legislative Update Luncheon, February 1, 2011
Speaker, "Mitigating Litigation, Product Liability & Product Approval Risks Facing Medical Device Manufacturers," 2nd Annual Medical Device, Durable Medical Equipment & Diagnostics Conference: Key Business & Legal Issues for Manufacturers & Distributors, McGuireWoods LLP Seminar, November 3, 2010
Speaker, "Brave New FDA – Changes in Washington," VBDC Symposium, April 2010
Speaker, "Legal Perspective: How to Interact and Avoid Potential Problems with the FDA," Medical Devices Summit 2010, March 2010
Speaker, "Current Healthcare Regulatory Climate: Fraud & Abuse Issues, False Claims & Other Hot Topics," 7th Annual Healthcare and Life Sciences Private Equity & Finance Conference: Healthcare and Life Sciences Investing: The Road to Recovery, February 2010
New FDA Guidance on Appeals Processes for Medical Device Denials, May 21, 2013
PhRMA Pushes for Permissive Off-Label Promotion Regime, May 15, 2013
FDA’s Aggressive Inspections Can Deep-Six Pending Filings, May 13, 2013
Bipartisan Bill Gives FDA Control over Certain Compounding Entities: Four Key Points, May 3, 2013
Compounding Pharmacy Oversight Remains a Priority for House Committee, February 7, 2013
FDA Seeks to Raise Metal-on-Metal Hip Implants to Class III and Issues New Safety Recommendations: Potential Retroactive Requirements, January 25, 2013
FDA Commissioner Calls for New Regulations on Compounding Safety, January 11, 2013
FDA Introduces New 510(k) Refuse to Accept Policy, January 10, 2013
Caronia: Second Circuit Finds FDA’s Off-Label Promotion Ban Unconstitutional, December 21, 2012
FDA Posts Shorter 510(k) and PMA Approval Times, December 6, 2012
FDA and State Officials to Discuss State and Federal Roles Regarding Compounding Pharmacies, December 4, 2012
Amendment to FDA’s Unique Device Identification Rules Shorten Proposed Compliance Deadline, November 27, 2012
FDA Commissioner Urges Congress to Expand FDA Authority to Regulate Compounding Pharmacies: GOP Demands Document Release, November 21, 2012
Markey Compounding Bill: Key Features of the Proposed Verifying Authority and Legality in Drug Compounding Act of 2012, November 16, 2012
November 7 Comment Deadline for FDA’s Unique Device Identification Rules: Three Key Points, November 6, 2012
Industry Comment Summary: Two Key Reasons Medical Device Companies Need Clear Guidance on Off-Label Communications, November 1, 2012
Another Attempt at a National Drug Track-and-Trace Proposal: Three Key Points, October 29, 2012
Office of Inspector General to Focus Enforcement on Five Areas of FDA Regulation, October 18, 2012
FDA Finally Concedes It Must Accept More Risk In Order To Spur Innovation, October 5, 2012
Which Medical Devices Are Taxable? : Agencies Have Conflicting Interpretations, September 28, 2012
Congress Passes Last-Minute Fix to Save FDA Generic Drug User Fee Funds: Leaves Unaddressed Device User Fee Funds, September 25, 2012
FDA Layoffs and Extended Approval Times Anticipated if Budget Cuts Trigger Loss of User Fee Funds, September 21, 2012
FDA Changes Device Listing and Registration Requirements, September 20, 2012
Detailed Summary and FAQ - New Proposed Medical Device Excise Tax Regulation, February 8, 2012
IRS Clarifies 2.3% Medical Device Tax and Requests Comments for Additional Exclusions, February 7, 2012
FDA Issues Draft Guidance on Modifications Requiring 510(k) Submissions, August 18, 2011
Third in Series: FDA Draft Guidance - Mobile Medical Apps: There's a Tweet For That, August 10, 2011
Second in Series: FDA Draft Guidance - Mobile Medical Apps: Cheat Sheet, August 3, 2011
First in Series: FDA Draft Guidance - Mobile Medical Apps, July 21, 2011
FDA Relaxes 510(k) Requirements on Certain IVD and Radiological Class I and II Devices, July 13, 2011
FDA Unveils 25 Initial 510(k) Changes, Refers Controversial Recommendations to the Institute of Medicine (IOM), January 21, 2011
FDA Releases Anticipated Preliminary Report Tightening Medical Device Regulations, August 4, 2010
DOJ's FCPA Team Pressing Forward with Pharma Probes, July 20, 2010
FDA Continues Litigating Tobacco Advertising Rules, July 15, 2010
CMS Proposes Rule to Cross-Privilege Physicians Practicing Telemedicine, June 22, 2010
Applications Due July 21 for New Therapeutic Discovery Project Tax Credit and Grant - Decisions by Oct. 29, June 2, 2010
Health Reform for the Life Sciences Industry, May 10, 2010
FDA Changes Medical Device Review Process, May 6, 2010
FDA Sharpens Enforcement Teeth: Pre-Warning Letter Executive Misdemeanor Charges Expected to Rise, April 27, 2010
Delaying Generic Drugs: The Legal Landscape Surrounding Reverse Payment Agreements to Protect Patent Holders, March 30, 2010
U.S. District Court Addresses Interplay Between the Food, Drug, and Cosmetic Act and the Family Smoking Prevention and Tobacco Control Act Regarding E-Cigarettes, January 25, 2010