Find Lawyers in Portland, Oregon for FDA Law
David Ernst is a seasoned trial lawyer and risk management counselor acclaimed for having “developed an impressive national reputation in food outbreak disputes” and “respected for his expertise in class actions relating to the food and beverage industries” by Chambers USA: “America’s Leading Lawyers for Business.” David is a recognized national leader for this type of work, regularly representing national restaurant chains, food manufacturers, and di...
FDA Law Definition
A number of statutes make up the regulatory scheme for these products in the United States, including most notably the Federal Food, Drug, and Cosmetic Act. There are also the Public Health Service Act, the Fair Packaging and Labeling Act, the Controlled Substances Act, the Poison Prevention Packaging Act, the Lanham Act, and numerous other federal, state, and local laws. Broader principles of administrative law and other laws governing administrative agencies such as the Freedom of Information Act also come into play. These laws are implemented and enforced by a range of regulatory authorities, including the United States Food and Drug Administration, the Drug Enforcement Administration, the Consumer Product Safety Commission, the United States Department of Agriculture, the Federal Trade Commission, and state agencies.
FDA Law practitioners apply their knowledge of the governing laws and agency practice to provide strategic advice to clients. For example, a lawyer in this field might guide clients on the best strategy for obtaining approval of a new drug or medical device, help a client respond to an adverse FDA inspection, review proposed marketing campaigns, or conduct internal investigations of quality or marketing practices. FDA Law practitioners also represent clients in enforcement proceedings, participate in legislative and agency rulemaking proceedings, and support corporate deals and other transactions. For example, an FDA Law practitioner might conduct regulatory due diligence for an acquisition or draft regulatory provisions of agreements or securities filings. FDA Law practitioners also represent clients in litigation involving underlying regulatory issues.
In selecting a lawyer for an FDA Law matter, clients should carefully consider the lawyer’s substantive expertise, along with his or her knowledge of the applicable regulators, and legal and practical judgment. The field is complex and at times arcane. There is no substitute for counsel with deep subject matter expertise and real world experience.
Recognition by Best Lawyers is based entirely on peer review. Our methodology is designed to capture, as accurately as possible, the consensus opinion of leading lawyers about the professional abilities of their colleagues within the same geographical area and legal practice area.
Best Lawyers employs a sophisticated, conscientious, rational, and transparent survey process designed to elicit meaningful and substantive evaluations of the quality of legal services. Our belief has always been that the quality of a peer review survey is directly related to the quality of the voters.
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