US
FDA: Medical Device
| FDA: Medical Devices — Highly Recommended |
|---|
| Hogan Lovells |
| Hyman Phelps & McNamara |
| King & Spalding |
| Sidley Austin |
| FDA: Medical Devices — Recommended |
|---|
| Arnold & Porter |
| McDermott Will & Emery |
| Morgan Lewis & Bockius |
| Ropes & Gray |
FDA: Pharmaceutical
| FDA: Pharmaceutical — Highly Recommended |
|---|
| Covington & Burling |
| Hogan Lovells |
| Hyman Phelps & McNamara |
| Sidley Austin |
| FDA: Pharmaceutical — Recommended |
|---|
| Arnold & Porter |
| King & Spalding |
| Morgan Lewis & Bockius |
| Ropes & Gray |
| Lawyer | Section | Practice Area | Location |
|---|---|---|---|
| Dormer, Robert A | Regulatory | FDA: Medical Device, FDA: Pharmaceutical | Washington, D.C. |
| Gibbs, Jeffrey N | Regulatory | FDA: Medical Device, FDA: Pharmaceutical | Washington, D.C. |
| Gilbert, John | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
| Karst, Kurt | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
| Kirschenbaum, Alan | Regulatory | Healthcare Pricing & Reimbursement, FDA: Pharmaceutical | Washington, D.C. |
| Sasinowski, Frank J | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
| Shapiro, Jeffrey | Regulatory , Non-IP Litigation & Enforcement | FDA: Medical Device, White-Collar/Govt. Investigations | Washington, D.C. |
| Torrente, Josephine | Regulatory | FDA: Pharmaceutical | Washington, D.C. |
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Regulatory
Hyman Phelps & McNamara
Hyman Phelps & McNamara is a boutique law firm that solely focuses on all FDA-related matters. The firm provides the full gamut of counseling and representation to the life science companies, which includes pharmaceutical and medical device clients alike. As a boutique with a central regulatory focus, Hyman Phelps provides clients with FDA expertise throughout all stages of product development, including pre-market approvals and compliance, to post-market labeling, advertising and promotion. A peer considers the firm to be "well regarded" in the FDA pharmaceutical space.
Jeffrey Gibbs offers his extensive experience handling FDA regulatory issues on behalf of clients in the life sciences industry. His active practice primarily involves counseling medical device companies. Gibbs assists with regulatory strategy, 510(k) clearances, approvals, and post-market regulation advice and guidance. For his outstanding career in the life sciences regulatory space, this year Gibbs was inducted into the LMG Life Sciences Hall of Fame.
On the pharmaceutical side, Frank Sasinowski assists pharmaceutical and biotechnology companies, in addition to patient organizations. His practice predominantly focuses on assisting clients developing new drugs, strategizing and guiding the clients through the FDA's pre-approval process.