by inpharmedia | Apr 27, 2021 | Blog, Regulatory
Every new drug must prove to be safe and effective to be approved by any health authorities. The new drug/therapeutic moieties invented are protected by a specific patent that allows the innovator firm or patent holder to enjoy the exclusivity to market the product...
by inpharmedia | Jan 9, 2021 | Blog, Regulatory
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...
by inpharmedia | Feb 9, 2020 | Blog, Product Development
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....
by inpharmedia | Jan 9, 2020 | Blog, Product Development
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...
