Navigating Refuse to Receive (RTR) Standards: Key Insights for Successful ANDA Submissions
The Refuse to Receive (RTR) standards play a critical role in the ANDA (Abbreviated New Drug Application) submission process, acting as the initial gatekeepers for regulatory approval. These standards are designed to ensure that submitted applications meet the necessary criteria for review by the FDA. A failed RTR decision can lead to delays, additional costs, and even the rejection of a submission. Understanding the key considerations surrounding RTR standards is essential for pharmaceutical...
Unlock Product Development with the Inactive Ingredient Database (IIG)
What is Inactive Ingredient Database? Inactive Ingredient Database (IIG) Database is a collection and aligned set of inactive ingredients, that are to be present or appeared in FDA approved drug products, allowing industry to access for development of new products. The first version of database made available in 1987 as hardcopy and an online database came to limelight in 2003. Inactive Ingredient An inactive ingredient is a component of a dosage form, other than the active ingredient, which...
Complete Guide to the Drug Development Lifecycle: From Discovery to Market Approval
The Lifecycle of a Drug (Pharmakon) or Biologic is initiated to address a disease or an ailment for which there is an unmet clinical need or to improve existing therapies. The Process involved in developing a new drug from the initial idea to the marketing of a finished product is a complex and stringent process that takes 12–15 years approx. and costs around $1 billion. Any development process should ensure that the drug possesses quality, safety efficacy and compliance with the regulatory...