FDA Interactions and Approvals – cGMP Compliance & Citizen Petitions
We have a robust counseling and compliance practice where we advise clients on matters relating to drug approval, drug marketing, supply chain management, and marketing and data exclusivity issues.
For FDA’s GMP compliance, we work with clients on responses to Form 483 Observation, Warning Letters, and Import Alerts. This is especially the case when data integrity issues are raised. While not initially evident, GMP compliance status can affect the 180-Day exclusivity, the ability to market the drug timely, prepare for at-risk launches, or capitalize on a contractual settlement launch date. We work with GMP consultants to ensure that remediation efforts are going well, effectively, and cost-efficient.
We help draft Citizen Petitions and responses. We know that CPs often raise technical issues requiring FDA interpretation. We also file or respond to CPs that raise legal questions involving Exclusivities and bioequivalence.