Covington is the recognized leader in representing clients on FDA and related regulatory matters involving human pharmaceuticals and biological products. We advise the world’s leading biopharmaceutical manufacturers, emerging companies, and the principal industry trade associations including PhRMA. We have five actively practicing alumni of the FDA Chief Counsel’s and Commissioner’s office and a deep bench of other lawyers with more than 100 years of combined experience in the field.
Our practice spans all aspects of human pharmaceutical and biologics regulation — from research and development to commercialization and end-of-lifecycle planning.
Our expertise includes:
- All aspects of clinical trials and good clinical practices, including clinical trial recruitment, informed consent, investigator financial disclosure, investigator misconduct, institutional review board (IRB) and data safety monitoring board (DSMB) issues, clinical research organization (CRO) arrangements, and investigational new drug (IND) requirements.
- FDA review strategies, including new drug application (NDA) and biologics license application (BLA) requirements, special protocol agreements (SPAs), advisory committee preparation, accelerated approval and priority review pathways, and dispute resolution.
- Good manufacturing practice (GMP) requirements, including FDA inspections, field alert and biological product deviation reports, recalls, and consent decrees.
- Drug safety and pharmacovigilance, including risk evaluation and mitigation strategies (REMS), adverse event reporting, labeling changes, and post-approval study requirements.
- FDA promotion rules and healthcare law compliance, including FDA Office of Prescription Drug Promotion (OPDP) enforcement, good reprint practices, medical information responses and other medical affairs activities, compliance with the PhRMA Code on Interactions with Healthcare Professionals, advice on fraud and abuse and the anti-kickback laws, OIG advisory opinions, Sunshine Act compliance, corporate integrity agreement (CIA) implementation, and drug sampling and the Prescription Drug Marketing Act (PDMA).
- Product lifecycle planning, including Hatch-Waxman.