Amin Talati advises clients on FDA regulation of biological and vaccine products under both section 351 of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. This work includes product license application and establishment license application approvals, export issues, manufacturing requirements, labeling and promotion, and reporting issues.

Our Biologics Services Include:

• Working with FDA’s Center for Biologics Evaluation and Research (CBER) to obtain licenses for various vaccines, toxoids, skin test antigens, allergenic extracts, blood and blood products
• Providing guidance on safety testing including toxicology, sensitivity, FDA site inspections and various clinical safety guidelines
• Consulting on import and export compliance requirements for prescription drugs
• Counseling on compliance issues relating to good manufacturing practices, record keeping, product recalls, market withdrawals and FDA inspections
• Advising on all aspects of packaging and labeling of biologics in compliance with FDA and FTC standards