The Food and Drug Administration (FDA) provides a barrier to market entry and use of unproven and unsafe products. For prescription drugs, the FDA approval process requires substantial evidence of efficacy and safety for specific clinical situations. Although approval is indication-specific, the FDA has a limited role once a drug is on the market. Recent draft guidelines covering manufacturers'...

One of the key underlying issues facing the development of all drugs, and particularly orphan drugs, is what kind of evidence the Food and Drug Administration (FDA) requires for approval. The Federal Food, Drug, and Cosmetic [FD&C] Act provides that for FDA to grant approval for a new drug, there must be “substantial evidence” of effectiveness derived from “adequate and well-controlled investig...

On 17 November 2020, the United States Food and Drug Administration (FDA) authorized first rapid SARS-CoV-2 assay that can be run entirely at home [1]. Created by Lucira Health, All-In-One ...

In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential "breakthrough" drugs or treatments that show dramatic responses in early-phase studies. Using this regulatory pathway, once a promising new drug candidat...

Introduction........................................................................................ 740 I. Pediatric Testing: A Historical Perspective of the “Therapeutic Orphan” ............................................................. 746 A. Past Attempts to Acquire Pediatric Labeling.................... 746 B. FDAMA Section 111—Pediatric Exclusivity...................... 749 C. FDA’s Ma...

Clinical investigators invoke a number of specific regulatory requirements if their study includes use of a pharmaceutical agent. Studies using a drug that has not been approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may require filing an Investigational New Drug (IND) application with the FDA. If a study meets specific regulatory exemption cri...

In December 2006, the Food and Drug Administration (FDA) announced it had completed its “risk assessment” on food from animal clones. Our report, “Not Ready for Prime Time: FDA’s Flawed Approach to Assessing the Safety of Food from Animal Clones” analyzes FDA’s risk assessment and its conclusion (stated in the Agency’s press release) that FDA “finds that meat and milk from clones of adult cattl...