FDA granted Qualified Infectious Disease Product (QIDP) Designation for ForCast Orthopedics’ lead program, FC001, for the treatment of periprosthetic joint infection (PJI).
PJI can threaten the function of the joint, the preservation of the limb and even the life of the patient. PJI is challenging to treat because the infecting bacteria adhere to the prosthesis and form a protective biofilm that can be resistant to standard systemic antibiotics.
FC001 is being developed to address these challenges by delivering a targeted antibiotic therapy directly into the infected joint using ForCast’s proprietary technology.
QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antifungal and antibacterial drugs that treat serious or life-threatening infections. These incentives include Fast Track designation, priority review and additional market exclusivity if the product is approved by FDA.
“We are very pleased to receive QIDP designation from the FDA,” said Peter Noymer, Ph.D., Executive Chairman and CEO of ForCast Orthopedics. “This represents an important milestone for the company as we progress our lead product through development and toward commercialization.”
FDA granted Qualified Infectious Disease Product (QIDP) Designation for ForCast Orthopedics' lead program, FC001, for the treatment of periprosthetic joint infection (PJI).
PJI can threaten the function of the joint, the preservation of the limb and even the life of the patient. PJI is challenging to treat because the infecting bacteria adhere...
FDA granted Qualified Infectious Disease Product (QIDP) Designation for ForCast Orthopedics’ lead program, FC001, for the treatment of periprosthetic joint infection (PJI).
PJI can threaten the function of the joint, the preservation of the limb and even the life of the patient. PJI is challenging to treat because the infecting bacteria adhere to the prosthesis and form a protective biofilm that can be resistant to standard systemic antibiotics.
FC001 is being developed to address these challenges by delivering a targeted antibiotic therapy directly into the infected joint using ForCast’s proprietary technology.
QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antifungal and antibacterial drugs that treat serious or life-threatening infections. These incentives include Fast Track designation, priority review and additional market exclusivity if the product is approved by FDA.
“We are very pleased to receive QIDP designation from the FDA,” said Peter Noymer, Ph.D., Executive Chairman and CEO of ForCast Orthopedics. “This represents an important milestone for the company as we progress our lead product through development and toward commercialization.”
Copy to clipboard 
