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The New Drug Application
| Content Provider | Scilit |
|---|---|
| Author | Monahan, Charles Babiarz, Josephine |
| Copyright Year | 2008 |
| Description | A single agency, the Food and Drug Administration (FDA), regulates a trillion dollarsof products, ranging from 80% of the U.S. food supply to all human health careproducts, electronic products that emit radiation, animal products, and cosmetics. In2006, that agency approved 101 new drugs, 10 biologic license applications, and 39devices under the premarket approval process and cleared 3217 devices1 and recalled4266 products in all categories.2 That single agency is responsible for shellfish, stents,over-the-counter (OTC) cough syrups, tetanus shots, artificial sweeteners, mam-mography standards, prescription drugs, vitamins, and lipsticks, not to mention thereadability of calorie and trans-fat information on a bag of potato chips. The economicimpact of the FDA is difficult to calculate, the scientific challenges and increasingmedical needs overwhelming, and the expectations contradictory. Book Name: FDA Regulatory Affairs |
| Related Links | https://www.taylorfrancis.com/chapters/edit/10.3109/9781420073553-4/overview-fda-drug-development-josephine-babiarz-douglas-pisano |
| DOI | 10.3109/9781420073553-4 |
| Language | English |
| Publisher | Informa UK Limited |
| Publisher Date | 2008-08-11 |
| Access Restriction | Open |
| Subject Keyword | Book Name: FDA Regulatory Affairs Thereadability |
| Content Type | Text |
| Resource Type | Chapter |
