Conducting Remote Regulatory Assessments Questions and Answers

Provides the opportunity to test, implement, and scale the integration of innovation into clinical trials through increased communication and interaction between CDER and sponsors of innovative clinical trials in certain project areas

The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.

Certain Broselow Pediatric Emergency Rainbow Tapes were manufactured with incorrect information on the tape.

Unapproved New Drug/Misbranded

FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.

CGMP/Finished Pharmaceuticals/Adulterated