Drugs & Biologics

Our firm provides advice on all aspects of drug and biologic research, development, and approval, including:

• Investigational New Drug Applications (INDs)
• New Drug Applications (NDAs)
• Abbreviated New Drug Applications (ANDAs)
• Biologics License Applications (BLAs)
• Drug and device combination products
• Amendments and supplements to applications
• Compliance with post-approval requirements for changes in products, labeling and manufacturing processes
• Establishment registration and product listing
• User fees
• FDA reporting requirements
• Orphan drugs and pediatric drugs
• Controlled Substances
• HIPAA and Privacy Issues

Our firm helps clients comply with FDA’s cGMP regulations by interpreting regulations, case law, agency guidance, and industry practice. We assist in responding to FDA inspectional observations, warning letters, and other enforcement actions relating to pharmaceutical quality.

Our firm advises on strategies for drug and biologic life-cycle management, including exclusivity for brand name and generic products, orphan drug and pediatric exclusivity, and antibiotic exclusivity. We also assist with bioequivalence and substitution issues under federal and state laws; and on patent issues applicable to FDA applications, such as patent registration and extension of patent terms. Our firm also handles legal issues relating to accelerated approval for new therapies for life threatening diseases.

Our firm represents clients in enforcement actions, including responses to FDA inspectional observations, warning letters, recall requests and import detentions, as well as more significant actions such as seizures and injunctions, negotiation of consent decrees, and implementation of FDA’s Application Integrity Policy (AIP).

Our firm supports clients in negotiating and drafting regulatory-related agreements such as guarantees, labeling agreements, supply agreements, quality agreements, etc. We also carry out due diligence analyses of drug and biologic companies and products that are being considered for acquisition or investment.