E-filing OTC drugs with the US FDA

Published: 10-Nov-2020

Ithos Global explains what was behind the US FDA’s requirement for drug manufacturers to submit drug registrations electronically, what the agency has done recently to enforce compliance, and how manufacturers and companies can meet these requirements

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First signed into law in 1938, the United States Federal Food, Drug, and Cosmetic Act (also known as the FFDCA or FD&C) was designed to protect consumers by improving food and drug safety standards.

The act required, for the first time, that drugs be labelled with directions for safe use and mandated that manufacturers prove to the Food and Drug Administration (FDA) that a drug was safe before it could be sold. It also prohibited false claims for drugs.

On 10 October 1962, President John F. Kennedy signed what became known as the Kefauver-Harris Amendments, which required drug manufacturers to prove to the FDA that their products were both safe and effective prior to marketing.

The amendments came in response to news about the drug thalidomide, a sedative used to treat morning sickness that also caused severe birth defects. The FD&C now had a framework of safety standards to protect consumers from dangerous or ineffective medications.

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