392 related articles for article (PubMed ID: 20302139)
1. US regulation of combination products.
Donawa M
Med Device Technol; 2009 Oct; 20(6):22, 24-5. PubMed ID: 20302139
[TBL] [Abstract][Full Text] [Related]
2. Understanding US labelling requirements.
Donawa M
Med Device Technol; 2005 Sep; 16(7):21-3. PubMed ID: 16259155
[TBL] [Abstract][Full Text] [Related]
3. FDA pilot programme in support of global harmonisation.
Donawa ME
Med Device Technol; 2003 Nov; 14(9):32-4. PubMed ID: 14682021
[TBL] [Abstract][Full Text] [Related]
4. New European guidance on borderline products.
Donawa ME;
Med Device Technol; 2009 Sep; 20(5):22, 24-5. PubMed ID: 19852178
[TBL] [Abstract][Full Text] [Related]
5. FDA set to tighten guidelines on industry dissemination of information on unapproved uses of medical products.
Lang L
Gastroenterology; 2008 Apr; 134(4):905. PubMed ID: 18395067
[No Abstract] [Full Text] [Related]
6. The US medical device bundling policy.
Donawa M
Med Device Technol; 2004 Nov; 15(9):25-7. PubMed ID: 16231784
[TBL] [Abstract][Full Text] [Related]
7. The new FDA combination products programme.
Donawa M
Med Device Technol; 2002 Oct; 13(8):25-8. PubMed ID: 12416330
[TBL] [Abstract][Full Text] [Related]
8. Combination products regulation at the FDA.
Lauritsen KJ; Nguyen T
Clin Pharmacol Ther; 2009 May; 85(5):468-70. PubMed ID: 19381151
[TBL] [Abstract][Full Text] [Related]
9. Successful recruitment for medical device clinical studies.
Donawa M
Med Device Technol; 2004 Oct; 15(8):25-7. PubMed ID: 16225270
[TBL] [Abstract][Full Text] [Related]
10. Meeting US and European supplier control requirements.
Donawa M
Med Device Technol; 2009; 20(3):24-7. PubMed ID: 19626952
[TBL] [Abstract][Full Text] [Related]
11. Medical device directive: preparing for the amendments.
Donawa M
Med Device Technol; 2000; 11(1):40-5. PubMed ID: 10915484
[TBL] [Abstract][Full Text] [Related]
12. Complying with US nonconforming product requirements.
Donawa M
Med Device Technol; 2007; 18(3):22, 24-5. PubMed ID: 17585716
[TBL] [Abstract][Full Text] [Related]
13. Beyond the US submisson process.
Donawa M
Med Device Technol; 2004 Apr; 15(3):30-2. PubMed ID: 15255536
[TBL] [Abstract][Full Text] [Related]
14. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.
Basile EM; Tolomeo D; Gluck E
Food Drug Law J; 2009; 64(1):149-69. PubMed ID: 19998744
[TBL] [Abstract][Full Text] [Related]
15. When to conduct a clinical trial.
Boutrand JP
Med Device Technol; 2004 Oct; 15(8):28-31. PubMed ID: 16225271
[TBL] [Abstract][Full Text] [Related]
16. European medical device regulation: a new era?
Donawa M
Med Device Technol; 2004 Dec; 15(10):30-1. PubMed ID: 16225282
[TBL] [Abstract][Full Text] [Related]
17. Medical device reporting: another final rule, Part I.
Donawa M
Med Device Technol; 2000 Mar; 11(2):40-2. PubMed ID: 10915493
[TBL] [Abstract][Full Text] [Related]
18. New US agent requirements.
Donawa M
Med Device Technol; 2002; 13(1):35-7. PubMed ID: 11921780
[TBL] [Abstract][Full Text] [Related]
19. Devices and the food and drug administration.
Phillips SJ; Phillips RS
Artif Organs; 2005 May; 29(5):363-5. PubMed ID: 15854210
[No Abstract] [Full Text] [Related]
20. Auditing device clinical studies for US requirements.
Donawa M
Med Device Technol; 2007 Oct; 18(6):24-7. PubMed ID: 18078178
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]