Format
Sort by

Send to

Choose Destination

Links from PubMed

Items: 1 to 20 of 103

1.

Immune monitoring: it's prudent to adopt current quality regulations.

Shankar G.

Trends Biotechnol. 2002 Dec;20(12):495-7.

PMID:
12443869
2.

The role of the reporting framework MIATA within current efforts to advance immune monitoring.

Janetzki S, Britten CM; MIATA Core Team.

J Immunol Methods. 2014 Jul;409:6-8. doi: 10.1016/j.jim.2014.05.003. Epub 2014 May 9. No abstract available.

PMID:
24816466
3.

Food and Drug Administration regulation and evaluation of vaccines.

Marshall V, Baylor NW.

Pediatrics. 2011 May;127 Suppl 1:S23-30. doi: 10.1542/peds.2010-1722E. Epub 2011 Apr 18. Review.

PMID:
21502242
5.

FDA attempting to overcome major roadblocks in monitoring drug safety.

Zielinski SL.

J Natl Cancer Inst. 2005 Jun 15;97(12):872-3. No abstract available.

6.

US regulation of combination products.

Donawa M.

Med Device Technol. 2009 Oct;20(6):22, 24-5.

PMID:
20302139
7.

Remarks at the Food and Drug Law Institute's 48th Annual Conference.

Niedelman SM.

Food Drug Law J. 2005;60(2):117-26. No abstract available.

PMID:
16097089
8.

Industry reneges on postmarketing trial commitments.

Bouchie A.

Nat Biotechnol. 2003 Jul;21(7):718. No abstract available.

PMID:
12833074
9.
10.

[Pharmaceutical product quality control and good manufacturing practices].

Hiyama Y.

Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2010;(128):1-16. Japanese.

PMID:
21381389
11.

Drug development history, "overview," and what are GCPs?

Heilman RD.

Qual Assur. 1995 Mar;4(1):75-9.

PMID:
8520867
12.
13.

Quality control and assurance from the development to the production of biopharmaceuticals.

Doblhoff-Dier O, Bliem R.

Trends Biotechnol. 1999 Jul;17(7):266-70.

PMID:
10370232
14.

The unfinished business of U.S. drug safety regulation.

Evans BJ, Flockhart DA.

Food Drug Law J. 2006;61(1):45-63. No abstract available.

PMID:
16838457
15.

Out in the open.

[No authors listed]

Nat Biotechnol. 2005 Feb;23(2):153. No abstract available.

PMID:
15696130
16.

Industry perspectives on ICH guidelines.

Rockhold FW.

Stat Med. 2002 Oct 15;21(19):2949-57.

PMID:
12325111
17.

Promoting, improving and accelerating the drug development and approval processes.

Graul AI.

Drug News Perspect. 2009 Jan-Feb;22(1):30-8. doi: 10.1358/dnp.2009.22.1.1303816.

PMID:
19209297
18.

Accelerated approval of oncology products: the food and drug administration experience.

Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R.

J Natl Cancer Inst. 2011 Apr 20;103(8):636-44. doi: 10.1093/jnci/djr062. Epub 2011 Mar 21. Review.

19.

China's perspective on similar biotherapeutic products.

Liang C, Wang J.

Biologicals. 2011 Sep;39(5):312-6. doi: 10.1016/j.biologicals.2011.06.020. Epub 2011 Sep 15. Review.

20.

Regulatory watch: impact of PDUFA on regulatory decision-making.

Hay M.

Nat Rev Drug Discov. 2010 Aug;9(8):585. doi: 10.1038/nrd3247. No abstract available.

PMID:
20671755
Items per page

Supplemental Content

Write to the Help Desk