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Drugs

Over-the-counter and prescription drugs, including generic drugs, are regulated by FDA's Center for Drug Evaluation and Research (CDER). This work covers more than just medicines.

Research and development of prescription drugs can be a complicated and costly endeavor.  C. Humphrey & Associates, P.A. FDA Attorneys are available throughout the process to help clients 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  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.

Whether it’s an NDA, paper NDA, ANDA, or BLA, C. Humphrey & Associates, P.A. FDA Attorneys are 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.  C. Humphrey & Associates, P.A. FDA Attorneys understand 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.  

Even after FDA approval is secure, prescription drugs require post-approval oversight.  C. Humphrey & Associates, P.A. FDA Attorneys can help establish or refine your compliance program and defend against enforcement actions that may arise.  C. Humphrey & Associates, P.A. FDA Attorneys 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. FDA Attorneys at C. Humphrey & Associates, P.A. 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.

The regulation of prescription drugs involves a number of critical, ancillary matters. C. Humphrey & Associates, P.A. FDA Attorneys understand the drug distribution process and  counsels clients on wholesale distribution, importation and re-importation, drug pedigrees and counterfeit drugs.  We assist in establishing the required Standard Operating Procedures (SOPs) for manufacturer facilities and help meet the requirements of the Application Integrity Policy (AIP).  Additionally, C. Humphrey & Associates, P.A. helps clients navigate drug recalls including developing a comprehensive strategy from risk assessment, to proper communication, through our effective evaluation.

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