Address for Regulatory Submissions Food and Drug Administration,Center for Drug Evaluation and Research,Division of XXXXX,5901-B Ammendale Road,Beltsville, MD 20705-1266. Investigational New Drug (IND) Applications Therapeutic Biological […]

There are two regulatory pathways to bring a nonprescription drug to market in the U.S. — the drug application process and Over-the-Counter (OTC) Drug Review (OTC […]

 1999-2003 BLA information is available in the FDA Archive The therapeutic biological products include: Monoclonal antibodies for in-vivo use Cytokines, growth factors, enzymes, immunomodulators; and thrombolytics […]

FDA aspires to continually improve its pre-ANDA (abbreviated new drug application) interactions with applicants. To facilitate these interactions and keep stakeholders as informed as possible, the […]

CDER researchers have conducted a randomized study to better understand how physicians make prescribing decisions. As they make decisions about which drug products should be prescribed […]

On This Page Date: June 6, 2024 Time: 9:30 AM – 10:40 AM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]