The regulatory environment faced by pharmaceutical and medical technology manufacturers is turbulent and unpredictable. Aggressive enforcement remains a key initiative for lawmakers, FDA, DOJ, OIG, and state attorneys general. Meanwhile whistleblower cases are increasing in popularity. We work with the regulators and prosecutors on your behalf to resolve cases and avoid enforcement escalation.
For more information, see our latest Alerts.
Representative matters:
- Responding to and resolving Warning Letters and Noticies of Violation, Untitled Letters, Form 483s Observations
- Working with District and National FDA Offices on resolving Import Alerts and Import Holds
- Negotiating Certificate to Foreign Government (“CFG”) holds with FDA
- Evaluating and facilitating Recalls and Field Corrections (Part 806), drafting recall communications, assisting with Health Hazard Assessments
- Negotiating with the FDA to reach amenable Consent Decree terms
- Performing FDA-ordered Compliance Reviews and making requisite FDA submissions
- Responding to FDA requests for additional information
- Helping prepare for FDA inspections
- Offering onsite guidance and monitoring during FDA inspections
- Designing and implementing policies and procedures
- Assisting with Medical Device Reports (“MDRs”)
- Offering registration and listing support
- Assisting companies subject to Corporate Integrity Agreements (CIA)
- Resolving FDA seizures executed by the U.S. Marshals Service and U.S. Customs and Border Protection
