Textual Modalities for: Biological products except diagnostic
Records: Showing 20 of 483 total records
Page: 8 of 25
| Code | Title | Description | Source | Word Counts | URL |
|---|---|---|---|---|---|
| 283699.0 | Considerations for the Use of Artificial Intelligence | This guidance provides recommendations to sponsors and other interested parties on the use of artifi... | Total words: 297 | biological: 2 | products: 4 | View | |
| 283699.0 | Subpart A—General Provisions - GovInfoPDF | (a) In vitro diagnostic products are those reagents, instruments, and sys-tems intended for use in t... | Total words: 4,504 | biological: 8 | products: 12 | except: 4 | diagnostic: 15 | View | |
| 283699.0 | Occupational Safety and Health Administration | 2836 Description for 2836: Biological Products, Except Diagnostic Substances; 3011 Description for 3... | Total words: 385 | biological: 1 | products: 8 | except: 2 | diagnostic: 1 | View | |
| 283699.0 | Prescription Drug User Fee Act Waivers, Reductions, and Refunds for ... | PHS Act, other than biological products that also meet the definition of a device in section 201(h) ... | Total words: 9,964 | biological: 22 | products: 35 | diagnostic: 2 | View | |
| 283699.0 | Intercenter Agreement Between the Center for Drug Evaluation and ... | CBER is the lead center for regulating biological products. Biological products are regulated under ... | Total words: 3,076 | biological: 15 | products: 60 | diagnostic: 3 | View | |
| 283699.0 | Principles and applications of polymerase chain reaction in medical ... | Since its description, this technology has caused a veritable revolution in biological research, est... | Total words: 9,934 | biological: 5 | products: 7 | except: 1 | diagnostic: 14 | View | |
| 283699.0 | “Deemed to be a License” Provision of the BPCI Act | The 10-year transition period between the law’s enactment on March 23, 2010, and March 23, 2020, p... | Total words: 778 | biological: 19 | products: 17 | except: 2 | View | |
| 283699.0 | An Introduction to Biotechnology - PMC | It is an amalgamation of biological science with engineering whereby living organisms or cells or pa... | Total words: 9,714 | biological: 5 | products: 32 | diagnostic: 3 | View | |
| 283699.0 | 5 MECHANISMS OF BIOLOGICAL EFFECTS - National Center for Biotechnology ... | Radiation ionizes cellular atoms and molecules; if immediate recombination does not occur, these can... | Total words: 6,502 | biological: 18 | products: 6 | except: 1 | View | |
| 283699.0 | Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products | Existing EUAs for products will remain in effect, and the agency may continue to issue new EUAs if t... | Total words: 1,221 | biological: 3 | products: 6 | View | |
| 283699.0 | Guidance for Industry - U.S. Food and Drug Administration | biological products including vaccines, allergenic products, therapeutics, plasma derivatives, and i... | Total words: 6,645 | biological: 31 | products: 32 | except: 1 | View | |
| 283699.0 | Definition of the Term “Biological Product” Final Regulatory Impact ... | The Food and Drug Administration is issuing a final rule to amend its regulation that defines "biolo... | Total words: 184 | biological: 4 | products: 1 | View | |
| 283699.0 | EDGAR Filing Documents for 0001193125-24-099071 - SEC.gov | SIC: 2836 Biological Products, (No Diagnostic Substances) (CF Office: 03 Life Sciences) ... | Total words: 136 | biological: 1 | products: 1 | diagnostic: 1 | View | |
| 283699.0 | eCFR :: 21 CFR 601.2 -- Applications for biologics licenses; procedures ... | (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for an... | Total words: 2,123 | biological: 13 | products: 11 | except: 2 | View | |
| 283699.0 | Foreign Quarantine; Import Regulations for Infectious Biological Agents ... | Any member of the animal kingdom except a human including an animal product (e.g., a mount, rug, or ... | Total words: 6,569 | biological: 37 | products: 7 | except: 2 | diagnostic: 8 | View | |
| 283699.0 | 21 CFR 809.10 -- Labeling for in vitro diagnostic products. | (a) The label for an in vitro diagnostic product shall state the following information, except where... | Total words: 4,681 | biological: 7 | products: 7 | except: 4 | diagnostic: 14 | View | |
| 283699.0 | 21 CFR 600.80 -- Postmarketing reporting of adverse experiences. | Adverse experience. Any adverse event associated with the use of a biological product in humans, whe... | Total words: 3,576 | biological: 18 | products: 13 | except: 2 | diagnostic: 1 | View | |
| 283699.0 | Guidance for Industry - U.S. Food and Drug AdministrationPDF | biological products including vaccines, allergenic products, therapeutics, plasma derivatives, and i... | Total words: 6,645 | biological: 31 | products: 32 | except: 1 | View | |
| 283699.0 | Clinical Research Regulation For India | ClinRegs | Central Drugs Standard Control Organization. As per the 2019-CTRules, IND-43, and IND-42, a sponsor ... | Total words: 30,488 | biological: 70 | products: 19 | except: 7 | diagnostic: 7 | View | |
| 283699.0 | Product Summaries - Animal and Plant Health Inspection Service | This page provides the public with summaries of safety and effectiveness (efficacy) studies used to ... | Total words: 172 | biological: 2 | products: 3 | diagnostic: 1 | View |
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