Generic drug manufacturers could face new regulatory requirements from FDA

FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to develop and implement safety-related changes to their labeling. If/when implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. Prior to this new rule generic companies could only change…

FDA Announces User Fees for Drugs, Devices, Biosimilars

The FDA Safety and Innovation Act (FDASIA) contains 140 pages of changes to the pharmaceutical industry, including a pronounced change to User Fees for Published Drugs and Biosimilar Products. These changes may have quite an impact on your strategic development plans, which addressing sooner rather than later can have a effect on your bottom line. …

Nanotechnology and FDA Regulation

Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated products, including medical products, foods and cosmetics. Nanomaterials, developed using nanotechnology, are measured in nanometers, — equal to about one-billionth of a meter — so small that they can’t be seen with a regu­lar microscope. These nanomaterials…

Omnipresent Literature Searches and Data Review Assignments

PDG assists the pharmaceutical industry to develop and maintain prescription and non-prescription drug products and devices.  Not surprisingly, we engage in a variety of regulatory activities involving literature searches and data evaluations to accomplish these tasks. On any given day you might find our staff developing Pre-IND/NDA meeting packages, developing FDA correspondence and regulatory submissions,…