FDA releases final guidance on companion diagnostics

FDA has recently released a final guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products, which are used in conjunction with therapeutic or biological products to maximize effectiveness based on the genetic characteristics of a patient or...

Register for the RAC fall exam cycle

The September 1 registration deadline is quickly approaching for this fall’s Regulatory Affairs Certification (RAC) exam. Apply now to earn the only globally recognized certification for the regulatory profession and stand among the most successful members of the...