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By Rakesh Gollen

Rakesh GollenNanotechnology is an emerging technology that can be used in a broad array of Food and Drug Administration (FDA)-regulated products, for purposes such as increasing the bioavailability of a drug. Recently, there has been an increased focus on using nanotechnology and nanomaterials in the development of novel drug delivery systems and targeted therapies. This focus is resulting in an increasing number of investigational new drug applications, new drug applications (NDAs), and abbreviated new drug applications for drug products containing nanomaterials to the FDA.

Although these drugs are subject to the same regulatory pathways and the same rigorous regulatory standards as any drug product approved by FDA, the unique properties that arise from nanomaterials’ small size and large surface areas may lead to additional scientific considerations when following current FDA guidelines and practices for drug evaluation. This is because the application of nanotechnology may result in product attributes that differ from those of conventionally manufactured products (which are already tested), and thus evaluations of safety or effectiveness of FDA-regulated products that include nanomaterials or otherwise involve the application of nanotechnology should consider the unique properties and behaviors that nanomaterials may exhibit.

A webinar on this topic has been organized by the AAPS Physical Pharmacy and Biopharmaceutics section and its Targeted Drug Delivery and Prodrug focus group, and it is scheduled for Thursday, July 2. In this webinar, Peng Zou, Ph.D., a chemistry reviewer at the Immediate Office, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA, will introduce the current regulatory pathways and regulatory requirements for drug products containing nanomaterial. In addition, the scientific considerations in the quality review of nano drug products (such as CMC review) and a number of related topics will be discussed. Drug delivery researchers/executives in pharmaceutical companies, regulatory personnel, and pharmaceutical consultants, among others, will benefit from this webinar. Interested AAPS members may register here.

Rakesh Gollen is currently pursuing his Ph.D. from Long Island University, with a major in Drug Metabolism and Pharmacokinetics, under the supervision of David Taft, Ph.D. His research focus is on the predictions of pharmacokinetic parameters in special population, using the physiologically based pharmacokinetics modeling approach.