Food and Drug Administration (FDA), Federal Trade Commission (FTC), United States Department of Agriculture (USDA) and Drug Enforcement Administration (DEA) Regulations
We have a great depth of experience in representing life science companies on federal regulatory matters, and in particular, matters wherein the FDA, FTC USDA and/or the DEA regulations are involved. Our services include:
-
Counseling clients in drafting 510k and Premarket Approval applications for medical devices.
-
Drafting Investigational New Drug (IND) and device applications which seek permission to enter the clinic.
-
Addressing clinical holds.
-
Drafting and filing New Drug Applications (NDAs) and notifications to the FDA where health claims are to be made for dietary supplements.
-
Drafting and filing Biological License Applications (BLAs).
-
Addressing GRAS/GRAE issues (generally recognized as safe (GRAS)/generally recognized as effective (GRAE)).
-
Counseling clients regarding Orphan Drug matters.
-
Fast-tracking the approval process.
-
Approval of drug devices and dietary supplements in the United States and the European Union.
-
Compliance with Good Manufacturing Practices (cGMPs).
-
Humanitarian Device Exemption issues.
-
Approval of new veterinary medicines.
-
Intervention on not-approvable letters.
-
Record retention issues.
-
Recalls of food products, seizures, labeling, advertising claims and related enforcement actions.
-
Preparing and submitting new product names to the FDA, EMEA and other regulatory authorities, including submissions under the new FDA drug name pilot submission project.
Federal Regulatory Representative Matters
-
Draft and file NDAs, PMAs and 510ks, and receive approval to market. Recent representative work includes: approval to market drug coated stents; pending applications for other pharmaceuticals; approval to market new orthotic devices; reversal of nonapproval letters for new pharmaceuticals.
-
Assist clients in filing for orphan designation.
-
Label review for compliance with food allergen labeling requirements.
-
Respond to warning letters related to marketing claims for drugs and devices.
-
Perform due diligence for companies engaging in asset sales, licensing or co-development deals or mergers.
-
Advise clients on regulations pertinent to functional food.
-
Advise clients as to when health claims can be made related to dietary supplements.
-
Review and advise clients on the appropriateness of its label for its over the counter product, including the use of testimonials.
-
Assist clients in negotiation of contract manufacturing agreements and cGMPS.
-
Represent clients in seizures.