FDA through a process known as an PDUFA (Prescription Drug User Fee Act), originally enacted in 1992. PDUFA allows the FDA to access more resources to quicken the drug approval process. Many important drugs have been approved through PDUFA, including medicines for cancer, AIDS and heart disease...
Manufacturers of over-the-counter (OTC) drugs can choose to seek FDA approval through the NDA process or under what’s known as an OTC monograph. A monograph is described as a “recipe book” because it specifies the acceptable ingredients, formulations, labeling and testing parameters for more...
MasterControl's FDA Approval Process is a Guideline for Companies to Help in Control and Manage Processes, Customer Complaints, MDR Reporting, Design Controls, Clinical Trial Projects and Supplier Management.
Reports on claims from aggressive Republican deregulators that Congress and the Food and Drug Administration (FDA) have become too controlling regarding the approval process for new drugs. Arguments that the FDA has moved beyond its role as consumer protector and acts as an abusive regulator that ...
The FDA (Food and Drug Administration) Drug Approval Process, 24-25 Feb 2025, organized by Management Forum. Find webinar details | Conference Locate (Clocate)
Navigating the FDA Approval Process for Your Software Based Medical Device
FDA Approval Process for Medical DevicesAll Class II and some Class I and Class III medical devices require 510(k) approval from FDA before they are sold in the US. As such, the FDA does not provide official ‘approval’ of medical devices but clears them for sale. How To Check if ...
Regulatory advice and assessment play an important role in the successful development of new drugs and radiopharmaceuticals for the treatment of urologic malignancies. Cooperation between the US Food and Drug Administration (FDA) and the pharmaceutical industry has led to the approval of more than 20 ...
(HealthDay)—In an effort to quickly develop drugs that could prevent or slow Alzheimer's, the U.S. Food and Drug Administration said it plans to relax the approval process for experimental medications for the memory-robbing disease.
"We're not saying that the FDA is not thorough and not rigorous in their evaluation of these new drugs at the time of their approval," he said. "But it should be made clearer to physicians and their patients that when a drug has been approved for use, sometimes we know a lot about...