OTC monograph is widely used as a rule book to detect the level of the OTC in the medicines. Nowadays, it is essential to take help from the monographs, so while having a treatment, it is essential to take help from the monographs that are really very important for you, as OTC drugs contain more…
Over-the-counter (OTC) drug products are a billion-dollar industry consisting of over one hundred thousand OTC drugs marketed currently. OTC drugs also known as nonprescription drugs are not held in the same class as prescription drugs since they do not have high toxicity requiring practitioner supervision. Similar to prescription drugs, there are FDA drug labeling requirements…
The agency held a public hearing on March 22-23, 2012 to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.” The hearing was preliminary with no…
The agency recently announced a public hearing to “obtain input on a new paradigm we are considering. Under this paradigm, the Agency would approve certain drugs that would otherwise require a prescription for nonprescription use (also known as over-the-counter or OTC) under conditions of safe use.” Please let us know if you plan to attend…
According to FDA, “This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the-counter (OTC) drug monograph system and to describe the process for submitting that information. FDA regulations set forth criteria and procedures by which…
On September 19, 2011, FDA published a Notice to Industry announcing its revised Guidance for Marketed Unapproved Drugs – Compliance Policy Guide, replacing the version previously released in June 2006. This guidance represents a shift in FDA’s approach to enforcement actions related to marketed drugs without approved NDAs, ANDAs or OTC monograph compliance. To learn…