The Center for Drug Evaluation (CDER), in 2017, developed an initiative to modernize CDER’s New Drugs Regulatory Program (NDRP). The initiative focuses on scientific leadership, benefit-risk [...]
The FDA approved a new Eli Lilly drug, Kisunla, that may help reduce the cognitive decline of Alzheimer’s patients by attacking the patient’s amyloid. The drug is the third FDA-approved drug of [...]
Pharmaceutical companies and advertisers should consult FDA’s CNN rule when designing television and radio ads for direct-to-consumer drug advertisements
In the last decade, the FDA’s Center for Devices and Radiological Health (CDRH) has implemented many new programs to help developers obtain authorization of medical devices
Individuals and companies that make and market aromatherapy products need to understand when the products may be considered drugs by the FDA and when the FDA will consider that the products are [...]
Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.
The FDA has approved Transcranial Magnetic Stimulation (TMS) treatments for depression and obsessive-compulsive disorders. Other treatments may be FDA-approved based on the substantial [...]