Our work for both prescription and nonprescription drug clients includes the full range of regulatory matters, such as establishment registrations and product listings, product approvals, labeling and advertising, record keeping and reporting, factory inspection and enforcement. Our product approval work includes advice with respect to abbreviated new drug, new drug, and Rx-OTC switch applications. We also advise clients regarding product liability issues in connection with clinical trials and marketing of drug products.
On the enforcement end, Amin Talati has advised clients on product seizures, recalls, injunctions, and criminal proceedings. We have also negotiated consent decrees and voluntary agreements arising out of FDA's scrutiny in drug and biologic good manufacturing practice and promotion issues.
Our Drug Law Services Include:
- Preparing and filing of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Rx-OTC Switch Applications
- Preparing and filing Drug Master Files for drug ingredients, packaging and other drug characteristics
- Advising on product liability issues in connection with clinical trials and marketing of Prescription, OTC and Homeopathic Drug products
- Advising on all aspects of labeling and advertising in compliance with the FDA and FTC requirements including the Prescription Drug Marketing Act
- Consulting on import and export compliance requirements for prescription drugs
- Negotiating consent decrees and voluntary agreements arising out of FDA's scrutiny in drug and biologic good manufacturing practice and promotion issues
- Assisting with Homeopathic and OTC Drug Monograph Products - 2656 Drug Facility Establishment and 2657 Drug Product Listing/NDC Submissions
- Providing guidance on safety testing including toxicology, sensitivity, FDA site inspections and various clinical safety guidelines
- Developing and implementing marketing and production strategies for generic drugs pursuant to the Hatch-Waxman Act of 1984
- Defending against product seizures, recalls, injunctions, and criminal proceedings