FDA, Exclusivities, 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 CP’s often raise technical issues requiring FDA interpretation. We also file or respond to CP’s that raise legal questions involving Exclusivities and bioequivalence. 

Exclusivity Issues

Our lawyers help clients understand and navigate the complex intersection of IP, patent, and antitrust laws, specifically on NDA’s, paper NDA/505(b)(2) applications, ANDA’s, suitability petitions for different forms, trademark issues in drug dosage forms (the issues related to size, shape, and color), the 180-Day Exclusivity, Orphan Drug Exclusivity (ODE), REMS protections, and other FDA related non-IP exclusivity.

For Branded Companies seeking NDA or 505(b)(2) approvals, please see our in-depth practice description HERE.

For Generic Companies seeking ANDA or 505(b)(2) approvals, please see our in-depth practice description HERE.

To learn more about our Medical Devices practice, please see our in-depth practice description HERE.

To learn more about our Patent Litigation expertise, please see our in-depth practice description HERE.

To learn more about our Commercial Litigation expertise, please see our in-depth practice description HERE.