Consumer articles about over-the-counter and prescription drugs.
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CDER International Program
CDER’s work with foreign stakeholders enables progress in the harmonization of scientific and technical standards and regulatory requirements among regulatory authorities.Innovative Science and Technology Approaches for New Drugs (ISTAND) Program
The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by encouraging development of DDTs that are out of scope for existing DDT qualification programs but may still be beneficial for drug development.Electrical Wheelchair Component Correction: mo-Vis BVBA Issues Correction for R-net Joysticks Due to a Firmware Error
mo-Vis BVBA is correcting R-net Joysticks due to a firmware error that may cause the wheelchair to ignore the neutral setting and move unexpectedly.FDA and Kratom
Kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.Ananeoo Wellness LLC – Online Advisory Letter
Advisory letter issued to Ananeoo Wellness LLC for the marketing of Ananeoo Cellular Nutrition & Detoxification on ananeoowellness.comCPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
ORA and CDER agree to replace and/or withdraw CPGs in favor of using guidance or procedural documents, as appropriate per GGP regulations.