ANDAs: Pre-Submission Facility Correspondence (PFC) Associated with Priority Submissions
Introduction The Abbreviated New Drug Application (ANDA) is a vital pathway for the approval of…
Types of Applications for Drugs and Biologics in U.S
The FDA regulates the approval and marketing of drugs, biologics, and other products in the U.S. Companies must navigate specific application processes to ensure compliance and streamline approvals. Key application types include the Drug Master File (DMF), Investigational New Drug (IND) applications, and various Drug Applications (NDAs and BLAs). The DMF safeguards proprietary information and facilitates regulatory reviews, while the IND designates drugs in clinical trials. Overall, the FDA's framework balances innovation with public safety, maintaining strict standards for product quality.
Navigating Refuse to Receive (RTR) Standards: Key Insights for Successful ANDA Submissions
The Refuse to Receive (RTR) standards are vital for the ANDA submission process, determining regulatory approval by ensuring applications meet FDA criteria. Applicants face delays or rejections for failing to adhere to these standards, necessitating an understanding of common pitfalls and strategies to improve the likelihood of successful submissions.
Master the Bioequivalence study report – Key Insights to interpret a BE Report
Introduction A Bioequivalence (BE) Study Report is a comprehensive document that outlines the findings and…
Controlled Correspondence: A Key Strategy in Generic Drug Development
Introduction: In the world of pharmaceutical manufacturing and regulation, generic drugs play an important role…
Types of Exclusivities and Incentive Periods by Global Health Authorities
Exclusivity: Exclusivity is exclusive marketing rights granted by the Health Authority upon approval of a…
Mastering the CTD: Harmonized and Regulatory Data Submissions
The Common Technical Document (CTD) is an internationally accepted format for drug applications, created by the International Council for Harmonisation (ICH). It standardizes submission processes, enhancing clarity and efficiency in regulatory documentation, particularly for pharmaceutical companies. Before the CTD, varying requirements led to redundancy and delays in approvals. The CTD facilitates global submissions by harmonizing data presentation, which reduces costs and time to market for drugs. Its modular structure includes administrative, summary, quality, non-clinical, and clinical sections, ensuring comprehensive regulatory compliance and streamlined evaluations.
FDA Enforcement Activities: Inspections, Warning Letters, and Import Alerts
The Food and Drug Administration (FDA) is responsible for ensuring that products under its jurisdiction,…
Types of Market Exclusivities and Implications on Forfeiture
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors:…