CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
Similar Posts
Ventilator Recall: Philips Respironics Removes Certain DreamStation Devices Due to Programming Errors That Can Result in Failed Therapy Modes
DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.Church & Dwight Co., Inc. Issues Voluntary Nationwide Recall of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs Due to Microbial Contamination
Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level.Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices
Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical DevicesHow to Participate in Emerging Technology Program (ETP)
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.Animal Model Qualification Program | AMQP
Information for requestors interested in submitting animal models for qualification to FDA’s Drug Development Tool (DDT) Programs.
