- Assisted in litigation regarding paragraph IV certification and whether a generic drug is entitled to 180-day exclusivity.
- Negotiated with FDA and U.S. Customs to remove import detentions on medical products.
- Negotiated with CMS to obtain new codes for medical devices under the Healthcare Common Procedure Coding System (HCPCS).
- Petitioned FDA regarding the requirements for an Abbreviated New Drug Application that utilized a complex innovator drug product as the reference listed drug (RLD).
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