Food & Drug Law Overview
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Our qualified’s Food and Drug group represents manufacturers and distributors of drugs, medical devices, foods, dietary supplements and cosmetics as well as other entities whose activities are regulated in whole or part by the U.S. Food and Drug Administration (FDA), such as pharmaceutical advertising agencies, trade associations, research institutions and clinical investigators, infomercial producers and retailers.
Our practice involves providing advice and assistance on product development and approval, day-to-day and project specific regulatory counseling, advice on advertising, labeling and marketing issues, transactional work and litigation and litigation assistance. Our goal in assisting FDA-regulated entities in all of these areas is to obtain rapid product approval, minimize regulatory and legal exposure and protect the interests of these companies in their valuable intellectual property, business reputation and goodwill and other assets.
Product Development and Approval
Using our extensive experience in presenting scientific and medical information before the FDA, we assist our clients in developing and obtaining approval for FDA-regulated products.
Specifically, we assist clients in developing and submitting, and in obtaining approval of:
- New Drug, Abbreviated New Drug, and Supplemental New Drug Applications;
- Orphan Drug Designation Requests;
- Medical Device Premarket Approval Applications and 510(k) Premarket Notifications;
- Food Additive Petitions;
- GRAS Self Affirmation Notifications for Food Ingredients;
- Health Claim Petitions for Food and Dietary Supplements; and
- Structure/Function Claim Notifications and New Dietary Ingredient Notifications for Dietary Supplements.
Our attorneys also counsel our clients on a wide variety of regulatory issues before the FDA involving both day-to-day counseling on routine matters and project-specific significant regulatory matters. Such counseling has included:
- Advice on all regulatory issues relating to exclusivity, patent term extension, patent infringement safe harbors, and patent infringement cases relating to the Hatch-Waxman Amendments;
- Responding to enforcement actions such as FDA 483s, Warning and Notice of Violation letters, civil penalty and debarment proceedings, seizures, injunctions, import detentions and import alerts;
- Preparation of Citizen Petitions to FDA and responding to comments on those Petitions and Petitions filed by others;
- Advice on Quality Systems Regulation (QSR) requirements for Medical Devices and on Good Manufacturing Practice (GMP) requirements for Drugs, Foods and Dietary Supplements, including audits, preparation of SOP’s, and preparation for FDA inspections;
- Development and implementation of product recall plans, and legal advice and representation involving potential and actual recall situations, and dealing with NDA field alerts;
- Advising on adverse experience reporting requirements;
- Advising drug and device manufacturers and clinical research institutions and clinical investigators on issues involving Informed Consent, IRB’s, IND’s and IDE’s, and HIPAA;
- Assisting clients with regulatory issues such as regulation of controlled substances and import-export issues involving related agencies such as the Drug Enforcement Administration (DEA), the U.S. Customs Services, the U.S. Department of Agriculture (USDA) and related state agencies;
- Assisting clients with federal and state manufacturer and distributor registration and product listing requirements; and
- Commenting on proposed FDA rulemaking.
Advertising, Labeling and Marketing
We also represent our clients before federal, state and non-governmental agencies that have oversight or authority over all aspects of product advertising as well as marketing. We have been effective advocates for our clients and bring extensive experience before agencies with jurisdiction over the approval of and content of advertising, labeling and other forms of communication, including, in addition to the FDA, the Federal Trade Commission (FTC), USDA and state agencies and attorneys general as well as the National Advertising Division of the Council of Better Business Bureaus (NAD).
Our practice also involves assistance to drug manufacturers, wholesalers and other entities regulated under the Prescription Drug Marketing Act, including advice on sampling, product distribution and return, reimportation and wholesaler registration requirements and requirements for storage and handling of prescription drugs.