Drug delivery: the strategic advantage of design controls.
An interesting dichotomy exists in the regulation of drug-delivery products. If they are regulated as devices, there is a strong likelihood that new products will be designed and developed under documented design control programmes. There is less chance of this if they are regulated as drugs. This article discusses the benefits and added value of designing and developing all drug delivery products under a documented design control programme.
Donawa
M E
ME
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D018795:Device Approval; D016503:Drug Delivery Systems / Q000592:standards*; D015195:Drug Design; D004335:Drug and Narcotic Control; D004867:Equipment Design; D005060:Europe; D006801:Humans; D014481:United States