Modernizing the New Drugs Regulatory Program

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 [...]

FDA Approves Kisunla, the third in a new class of Alzheimer’s Drugs

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 [...]

FDA Guidance on Direct-to-Consumer Prescription Drug Advertisements

Pharmaceutical companies and advertisers should consult FDA’s CNN rule when designing television and radio ads for direct-to-consumer drug advertisements

How Developers Can Benefit from the FDA’s Center for Devices and Radiological Health (CDRH) New Innovation Policies

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

Aromatherapy and FDA Compliance

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 Intelligence Uses in The Healthcare Industry

Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.

FDA Grants Accelerated Approval for a New Alzheimer’s Disease Treatment

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

The FDA Transcranial Magnetic Stimulation Approval Process

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 [...]

Understanding the Medical Device Classification and Approval Process – Part Two

Developers and manufacturers of medical devices need to understand 510 (k) approval of medical devices and other FDA compliance issues.

Understanding the Medical Device Classification and Approval Process – Part One

Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval