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The Regulatory Affairs is a part of the Food and Drug Administration (FDA) that enforces the laws governing biologic, drugs,
medical devices, etc. which may have potential side effects for the consumers. Transdermal delivery is used to administer
drugs via the skin, for systemic or local use. Transdermal drug delivery represents a promising alternative to oral, intravascular
and subcutaneous routes. The first US transdermal drug delivery system (TDDS) was approved by the FDA more than 30 years
ago. Despite this length of time and the advancement of science in many other pharmaceutical fields, little has changed or
evolved in the development and control of these products. Over the years, various product quality problems have been reported
by patients and practitioners. Some of these quality problems have a safety and efficacy implications that have led to the recall
of numerous batches of products and, in some cases, the temporary or permanent removal of the product from the market.
Regulatory agencies worldwide is constantly raising the bar with more stringent interpretation of existing and new regulations
with government increasing focus and attention towards patient safety and costs of health care. The worldwide transdermal
delivery market is growing at about $2 billion per year. The yearly U.S. market for transdermal patches is projected to exceed $3-
plus billion. Industry analysts predict that the transdermal delivery market will rise from $21.5 billion during 2010 to $31.5 billion
in 2015. The present review focuses on different approved polymers, Chronological Events in Transdermal Drug Delivery System
and FDA Approvals and more importance is given to Regulatory Requirements for TDDS in U.S U.K, Japan and Asian countries.
C. Kishore completed Bachelors in Pharmacy from Sri Venkateshwara College of Pharmacy affiliated to Osmania University , Hyderabad and now
pursuing a Masters in Pharmacy (second semester) from Department of Pharmaceutics, G. Pulla Reddy college of Pharmacy.
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