FDA Requests Input On Development Of User Fee Program For Biosimilar And Interchangeable Biological Products
The U.S. Food and Drug Administration is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications. Biological products are produced in a living system such as a microorganism, plant, or animal cell, while small molecule drugs are typically made through chemical synthesis...

FDA, FTC Act To Remove Fraudulent STD Products From The Market
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) today announced a joint effort to remove products from the market that make unproven claims to treat, cure, and prevent sexually transmitted diseases (STDs). Among the products targeted in today's action are Medavir, Herpaflor, Viruxo, C-Cure, and Never An Outbreak. The agencies issued multiple letters to ...