FDA Comment Request: Establishing a unique device identification system for medical devices

The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. Continue reading

Performing Under PDUFA: The FDA Wants to Hear From You

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program). Continue reading

Sensitive test helps improve vaccine safety

Salmonella Typhi (S. Typhi) is the causative agent of typhoid fever, a serious health threat resulting in some 22 million new cases yearly and approximately 217,000 fatalities. A number of novel vaccine candidates using live attenuated strains of Salmonella are being developed, but care must be taken to ensure the bacteria are not excreted into the environment following vaccination.Continue reading