V-CARD
PHONE
+1 202 637 6585
FAX
+1 202 637 5910
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Meredith
Manning
Partner, Washington, D.C.
meredith.manning@hoganlovells.com
Meredith Manning is the Co-director of Hogan Lovells' pharmaceutical and biotechnology practice group. She primarily counsels companies in the pharmaceutical industry on an array of issues surrounding the U.S. Food and Drug Administration's (FDA) review, approval, and oversight of drug and biological products. She has broad experience addressing issues surrounding clinical trials, drug and biologic drug approval standards, and FDA compliance. She counsels clients concerning enforcement matters threatened or brought by the FDA and other regulatory bodies, including issues surrounding advertising and promotion of drugs and good manufacturing practices. This includes counseling companies about anticipated enforcement, responding to FDA inspectional observations, notices of violations and warning letters, and negotiating consents decrees with the FDA and the U.S. Department of Justice (DOJ).
Meredith has substantial government litigation experience, especially with respect to enforcement of the Federal Food, Drug and Cosmetic Act. She served as Assistant U.S. Attorney, Civil Division for the U.S. Attorney's Office in Washington, D.C., and was Associate Chief Counsel in the Office of the General Counsel at the FDA.
REPRESENTATIVE EXPERIENCE
- Routinely assists major pharmaceutical and biotechnology companies in assessing their compliance programs and in reviewing and revising policies and procedures governing compliance with the FDA's rules and regulations.
- Conducts internal investigations surrounding drug compliance practices such as assessments of promotional review committees, inquiries based on hotline complaints, and evaluations of the roles of medical and scientific personnel.
- Represents companies and individuals with respect to current Good Manufacturing Practices and in cGMP enforcement matters brought by FDA in federal court.
- Drafts comments to the FDA's administrative docket concerning pending policy issues, such as drug approval and REMS standards, drug advertising, and agency enforcement policy.
- Assists companies in appealing FDA actions and decisions, such as FDA conduct and management of advisory committees and the issuance of complete response letters.
- Assists a major biotechnology company in creating, negotiating, and managing Risk Evaluation and Mitigation Strategy (REMS) obligations under the Food and Drug Administration Amendments Act (FDAAA).
- Counsels a major biotechnology company on clinical trial obligations including issues involving informed consent, IRB review and approval, site monitoring, and data analysis and reporting.
- Routinely provides advice regarding safety reporting and analysis for investigational and marketed drug products.
Hogan Lovells Publications
28 February 2012
"Center for Drug Evaluation and Research presentation summary." Health Alert, Hogan Lovells
10 February 2011
"Former GSK lawyer moves to dismiss indictment: United States v. Lauren Stevens (D. Md. November 9, 2010)." Medical Device Alert, Pharmaceutical and Biotechnology Alert, Health Alert, and White Collar Alert, Hogan Lovells
21 September 2010
"CMS and FDA Announce New Parallel Review Process for Medical Products." Health Alert, Hogan Lovells
Published Works
27 January 2012
"Off-Label Guide Could Prompt Re-Evaluation Of Public Presentation Policies." Daily News, InsideHealthPolicy.com
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