William A. Garvin
- Advised clients regarding threatened litigation and settlement for false and misleading advertisements under California Civil Code and California Business and Professional Code.
- Registered medical device companies and listed their products with the FDA.
- Petitioned the DEA for the downscheduling of a drug product.
- 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.
- Helped clients work with members of Congress so that they could provide input regarding proposed legislation and highlight arbitrary enforcement actions by federal and state agencies.
- Reviewed and revised the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with the Federal Food, Drug and Cosmetic Act.
- Negotiated with CMS to obtain new codes for medical devices under the Healthcare Common Procedure Coding System (HCPCS).
- Negotiated with FDA regarding the recall of a product found to be violative.
- Submitted Citizen Petition to clarify regulatory status of drug products that do not require prior approval because they are part of an unresolved Notice of Opportunity for a Hearing ("NOOH") under the Drug Efficacy Study Implementation ("DESI") Review Pr
- Provided counseling and helped draft responses to FDA warning letters.
- Assisted in litigation to correct a patent listing within FDA's Orange Book.
- Petitioned FDA to recognize certain old drug products as being Generally Recognized as Safe and Effective (GRAS/E).
- Petitioned FDA regarding the requirements for an Abbreviated New Drug Application that utilized a complex innovator drug product as the reference listed drug (RLD).
- Prepared requests to FDA for orphan drug designations and minor use and minor species (MUMS) designations.
