Drug applications submission to us fda Over the counter Drugs OTC drugs

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Lakshmana Pramod's picture

Over-the-Counter drugs are defined as drugs that are safe and effective for use by the general public without a prescription. There are more than 80 classes (therapeutic categories) of OTC drugs, ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. FDA has been evaluating the ingredients and labeling of these products as part of "The OTC Drug Review Program." The goal of this program is to establish OTC drug monographs for each class of products. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without further FDA clearance, while those that do not, must undergo separate review and approval through the "New Drug Approval System." FDA's review of OTC drugs is primarily handled by CDER's Office of Nonprescription Drug Products. However, scientists and regulators throughout CDER, the Office of General Counsel, and other Centers within FDA are routinely asked to assist in this massive effort. There is also an advisory committee, "The Nonprescription Drug Advisory Committee," which meets regularly to assist the agency in evaluating issues surrounding these products. Additional information regarding the OTC Monograph Review process can be found at the following URL: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssista... OTC Ingredient List (Alphabetically) http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135688.pdf OTC Ingredient List (By Monograph Category) http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135691.pdf OTC Labeling Questions and Answers http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm150436.htm OTC Drug Review (3-phase public rulemaking process) The OTC drug review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States before May 11, 1972. It is a three-phase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of standards (monographs or non-monographs) for an OTC therapeutic drug category. The first phase was accomplished by advisory review panels. The panels were charged with reviewing the ingredients in nonprescription drug products to determine whether these ingredients could be generally recognized as safe and effective for use in self-treatment. They were also charged with reviewing claims and recommending appropriate labeling, including therapeutic indications, dosage instructions, and warnings about side effects and preventing misuse. According to the terms of the review, the panels classified ingredients in three categories as follows: * Category I: generally recognized as safe and effective for the claimed therapeutic indication; * Category II: not generally recognized as safe and effective or unacceptable indications; * Category III: insufficient data available to permit final classification The second phase of the OTC drug review was the agency's review of ingredients in each class of drugs, based on the panel's findings, on public comment, and on new data that may have become available. The agency, in turn, publishes its conclusions in the Federal Register in the form of a tentative final monograph. After publication of the tentative final monograph, a period of time is allotted for objections to the agency's proposal or for requests to be submitted for a hearing before the Commissioner of FDA. The publication of final regulations in the form of drug monographs is the third and last phase of the review process. The monographs establish conditions under which certain OTC drug products are generally recognized as safe and effective.

G.L.Pramod, B.Pharmacy, MS.c(Ph.Regulatory Affairs), Executive, EU Regulatoty Affairs, ELC, Ahemdabad.

Pushpendra Jain's picture

thnx 4 comments Lakshmana Pramod

Mind Hunter; Jiyo aur Jine do

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