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Regulators and Regulations
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray
The FDA initiated an action to remove from the market those Drug products that lacked proof of efficacy. This process was known as the Drug Efficacy Study Implementation (DESI) project. The process took a number of years (until 1984) and had a profound effect on the science of Drug development. The NDA was henceforth center stage.
The Food and Drug Administration
Published in Stanley R. Resor, Henn Kutt, The Medical Treatment of Epilepsy, 2020
In 1991, 17 antiepileptic drugs (AEDs) were marketed in the United States (Table 1). As a result of the Drug Amendment Act of 1962, drugs approved for marketing between 1938 and 1962 on the basis of safety alone were required to be reviewed for efficacy. The National Academy of Sciences/National Research Council (NAS/NRC) was asked to evaluate the efficacy claims for each indication of approximately 4000 drug formulations (10,11). The FDA has published periodic compilations of drugs included in the efficacy review as part of the Drug Efficacy Study Implementation Project (DESI) (12). The following brands of AEDs have been evaluated: Dilantin® (phenytoin), oral (13,14); Dilantin®, powder for injection, parenteral (IS); Zarontin® (phensuximide), Celontin® (methsuximide), Feganone® (ethotoin), Tridione® (trimethadione), Paradione® (paramethadione), Mesantoin® (mephenytoin), Gemonil® (metharbital), and Phenurone® (phenacemide), all oral (15).
Regulatory Standards for Approval of Topical Dermatological Drug Products
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
April C. Braddy, Dale P. Conner
The Federal Food, Drug, and Cosmetic Act (FFD&C Act) of 1938 requires that safety be established for all drug products prior to marketing approval. It wasn’t until the 1962 Kefauver-Harris Amendments that a drug product must be shown to be efficacious as well as safe (U.S. FDA 2012b). In between that 24-year time period, numerous drug products were approved. In order to address this problem of potentially ineffective drugs, in 1966 the U.S. FDA commissioned the National Academy of Sciences/National Research Council to evaluate the efficacy of all drug products approved between 1938 and 1962. Based on the results of this extensive project, many products were deemed effective and thus classified as drug efficacy study implementation (DESI) drugs (Federal Register 2012 & National Academy of Sciences 1972). This listing includes all types of topical dermatological drug products. In fact, in 1953, the first topical corticosteroid, Hydrocortisone Acetate Ointment (Cortef Acetate), was approved by the U.S. FDA based on an NDA submission. The application for this product was not approved based on comparative clinical trials. Hydrocortisone Acetate Ointment is currently listed as a DESI (Drug Efficacy Study Implementation) drug product for the 1%, 1.5% and 2.5% dosage strengths. According to the current federal regulations, 21 Code of Federal Regulations (CFR) 320.22 (c) (U.S. Code of Federal Regulations 2013), a waiver from in vivo bioavailability and BE study requirements may be granted for a DESI drug product.
Emerging topical drugs for the treatment of rosacea
Published in Expert Opinion on Emerging Drugs, 2021
Federica Dall’Oglio, Maria Rita Nasca, Giuseppe Micali
Rosacea generally encompasses a heterogeneous group of clinical phenotypes including diffuse persistent erythema and/or telangiectasias (due to dilated deep/superficial vessels) with or without inflammatory lesions (small, dome-shaped inflammatory papules, sometimes with superimposed pinpoint pustules or crusts, mostly symmetrically arranged). Current topical treatments for cutaneous rosacea include traditional (azelaic acid and metronidazole) and new prescription drugs (brimonidine, oxymetazoline, ivermectin, minocycline), all approved for use in rosacea by the US Food and Drug Administration (FDA), and one agent (sodium sulfacetamide with or without sulfur) not FDA-approved due to limited efficacy data but formally supported by the Drug Efficacy Study Implementation Program developed for evaluation of pre-1962 drugs [27,28]. These drugs can target specific phenotypes such as diffuse centrofacial persistent erythema (brimonidine, oxymetazoline) or inflammatory rosacea (ivermectin, minocycline, azelaic acid, metronidazole, sodium sulfacetamide-sulfur). If these drugs are contraindicated or ineffective, several non-FDA-approved off-label alternative topical agents may be considered including calcineurin inhibitors, nicotinamide derivatives, antiparasitic acaricidal agents, antimicrobials, retinoids, dapsone, and tranexamic acid.
Safety of recombinant human hyaluronidase PH20 for subcutaneous drug delivery
Published in Expert Opinion on Drug Delivery, 2021
Stephen P. Knowles, Marie A. Printz, David W. Kang, Michael J. LaBarre, Renee P. Tannenbaum
The approval of HYLENEX by the US Food and Drug Administration (FDA) in 2005 was in part reliant on the FDA’s finding of the effectiveness of hyaluronidases from the Drug Efficacy Study Implementation (DESI) review in 1970, and the results from a study of healthy volunteers that assessed hypersensitivity [5]. The DESI review established the efficacy of three animal-derived hyaluronidases based on many years of clinical use, and this formed the basis of the HYLENEX label [5]. The safety information in the HYLENEX label, based on the DESI review, is consistent with that of the currently marketed animal-derived hyaluronidases VITRASE® (an ovine-derived hyaluronidase) and AMPHADASE® (a bovine-derived hyaluronidase) [10,11,13].