Whether you are a large international corporation with an established product line or a small, local company seeking to introduce a first-time drug, Fuerst Ittleman can help you meet the sophisticated regulatory requirements involved with prescription drugs. Fuerst Ittleman assists clients from early on in the research and development process and throughout post-approval obligations including a myriad of ancillary responsibilities and regulatory requirements.
Research and Development
Research and development of prescription drugs can be a complicated and costly endeavor. Fuerst Ittleman is available throughout the process to help clients satisfactorily navigate the process and properly position themselves for efficient approval. We can help determine the need for an Investigational New Drug Application (IND) and facilitate pre-IND meetings with FDA officials. We can advise on Phase I, Phase II, Phase III, and Phase IV research studies for compliance with state and federal rules and regulations, including the Common Rule (45 C.F.R. Part 46) and local Institutional Review Boards.
Application Submission
Whether it’s an NDA, paper NDA, sNDA, ANDA, or BLA, Fuerst Ittleman is available to help achieve FDA approval and secure proper exclusivity. We advise clients on labeling, current good manufacturing practices (cGMPs), FDA review dates and accelerated approval pathways. Fuerst Ittleman understands the complex regulatory scheme under the Hatch-Waxman Act including Authorized Generics, Therapeutic Equivalents, patent listing in the Orange Book, Paragraph IV Certifications, and the application of pediatric exclusivity requirements. Our Tax Practice help clients realize the tax benefits of Orphan Drug designation and the costs incurred with the Prescription Drug User Fee Act (PDUFA). Additionally, Fuerst Ittleman helps clients conduct thorough Risk Evaluation and Mitigation Strategies (REMS) for prescription drugs ensuring safe drug use through medication guides, patient package inserts, and consumer medication leaflets for the pharmacy and other Risk Minimization Action Plans (RiskMAP guidance). Fuerst Ittleman can also counsel clients on veterinary drug applications including NADA, ANADA, and CNADA.
Post-Approval Obligations and Guidance
Even after FDA approval is secure, prescription drugs require post-approval oversight. Fuerst Ittleman can help establish or refine your compliance program and defend against enforcement actions that may arise. Fuerst Ittleman can help you understand the regulations involved with Direct-to-Consumer Advertising (DTCA) and help prepare submissions to DDMAC and APLS so that fair-balance is achieved within your promotional materials. Attorneys at Fuerst Ittleman bring experience with FDA’s MedWatch program and the Vaccine Adverse Event Reporting System (VAERS) to help clients meet reporting requirements and deal with safety alerts and enforcement proceedings including Dear-Doctor letters and Black-Box warnings, among others filed by FDA after a prescription drug has been approved.
Ancillary Concerns
The regulation of prescription drugs involves a number of critical, ancillary matters. Let Fuerst Ittleman assist you. Fuerst Ittleman Attorneys understand the drug distribution process and can counsel clients on wholesale distribution, importation and reimportation, drug pedigrees and counterfeit drugs. We can help establish required Standard Operating Procedures (SOP) for manufacturer facilities and help meet the requirements of the Application Integrity Policy (AIP). Additionally, Fuerst Ittleman Associates help clients navigate drug recalls including developing a comprehensive strategy from risk assessment, to proper communication, through effectiveness evaluation.
