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Articles from BioResearch Compliance Report (February 1, 2007)

1-10 out of 10 article(s)
Title Author Type Words
BiMo inspection FOIA log. Brief article 193
CBER steps up test kit audits as CDER charts deficiencies from inspections; 3% are OAI. Swain, Liz Clinical report 796
Drug makers fail to begin 71% of promised post-marketing studies. Mashaw, Rebecca 493
Duke IRB vice chair urges building safety into policy and procedures. Swain, Liz 714
Errors on informed consent forms could lead to broader FDA review, inspector says. Swain, Liz 538
FDA inspection should end with no surprises. Swain, Liz 675
FDA, VA to share information on safe use of medical products. Mashaw, Rebecca 305
Hoffman-La Roche cited for QA failures in 12-item 483. Roche, Hoffman-La 523
Protocol and case history violations net 2-item 483 for CI. Sarkane, Rudite 585
Warning letters. 641

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