Articles |
 Page 1 of 9  |
Pre-approval audit finds investigational plan not followed, incomplete...
December 01, 2005
|
FDA fine-tuning its position on trials controlled by placebo.(Placebos...
December 01, 2005
|
Sponsors need to assure GCP compliance to reduce legal liability.(Spon...
December 01, 2005
|
Patient privacy, informed consent becoming key issues in clinical tria...
December 01, 2005
|
Trial design, exclusion criteria, vulnerable groups seen causing trial...
December 01, 2005
|
Liability, federal rules dissuade use of alternative and central revie...
December 01, 2005
|
BiMo FOIA Log.
December 01, 2005
|
IRB determination letters.
December 01, 2005
|
NIDPOE letters.(Brief Article)
December 01, 2005
|
Warning letters.(Case study of Spencer Jones)
December 01, 2005
|
Minor deficiencies noted, but CI lauded for good documentation and tho...
November 01, 2005
|
Ritch escapes 483, but inspector warns CI is responsible for "ass...
November 01, 2005
|
CRO cited in 3-item 483 for omitting numerous protocol objectives, pro...
November 01, 2005
|
Warning letters.
November 01, 2005
|
NIDPOE letters.
November 01, 2005
|
IRB determination letters.(Brief Article)
November 01, 2005
|
BiMo FOIA Log.(Brief Article)
November 01, 2005
|
FDA BiMo Initiative focusing on greater use of central IRBs, reforming...
November 01, 2005
|
New FDA acting commissioner indicates faster drug approvals and strong...
November 01, 2005
|
Directive requires 'third' countries to comply with GCPs to support EU...
November 01, 2005
|
Assigning QA responsibilities in conduct of non-clinical trials seen a...
November 01, 2005
|
'Regulatory compliant research' advised to firms seeking to comply bet...
November 01, 2005
|
Galbraith Labs fails to follow SOPs in 3 analytical investigations.
November 01, 2005
|
Varied IT systems and excessive paper seen complicating GCP compliance...
October 01, 2005
|
FDAer urges trial sites to be 'gracious hosts,' even faxing map and di...
October 01, 2005
|
Copernicus Group IRB rep outlines better consent-form writing.(Informe...
October 01, 2005
|
ChiRhoClin done in by lack of written procedures for post-marketing AD...
October 01, 2005
|
IRB determination letters.
October 01, 2005
|
BiMo FOIA log.(Freedom of Information Act)(Brief Article)
October 01, 2005
|
State trial compliance rules vary, attorney says; insurance industry s...
October 01, 2005
|
OHRP eyeing guidance on incident reporting, IRB review of web sites.(A...
October 01, 2005
|
IDEC nets 10-item 483 for inadequate adverse event reporting.(Clinical...
October 01, 2005
|
Warning letters.
October 01, 2005
|
More 483 violations for international clinical investigators in 2004 h...
September 01, 2005
|
Getting consent of family, quizzing subjects suggested.(Informed conse...
September 01, 2005
|
Canby at Texas Cardiac receives 1-item 483 for case history flaws.(Cli...
September 01, 2005
|
Chan cited in two 483 violations for faulty informed consent procedure...
September 01, 2005
|
Warning letters.
September 01, 2005
|
IRB Determination Letters.
September 01, 2005
|
BiMo FOIA log.(Freedom of Information Act)
September 01, 2005
|
Consider a variety of late-phase training options for PIs and SCs, inc...
September 01, 2005
|
The regulation of clinical trials under state laws.(Guest Column)
September 01, 2005
|
CAPA programs for clinical research not required by FDA rules, but ess...
September 01, 2005
|
Sponsor-investigator cited for failure to submit IND in 8-item 483.
September 01, 2005
|
500 institutions seen accredited voluntarily by 2010; AAHRPP head says...
August 01, 2005
|
CDER gets 200 investigator misconduct complaints in 2004, but few audi...
August 01, 2005
|
FDAer urges submission of applications with SDTM datasets; possibly ma...
August 01, 2005
|
Subcommittee says continuing review must be simplified and permissive,...
August 01, 2005
|
DeSilva escapes 483, but SAEs and numerous documentation errors noted ...
August 01, 2005
|
Perryman cited for case history flaws and failing to follow entire inv...
August 01, 2005
|
Protocol deviations noted for Riff, no 483 issued.(clinical investigat...
August 01, 2005
|
Warning letters.
August 01, 2005
|
IRB Determination Letters.
August 01, 2005
|
BiMo FOIA log.(Brief Article)
August 01, 2005
|
OHRP, FDA need to produce joint, consolidated guidance on expedited re...
August 01, 2005
|
While quantity of warning letters drop, severity rises, especially wit...
July 01, 2005
|
CI receives 1-item 483 for SAEs, subject screening, drug records.(Clin...
July 01, 2005
|
Warning letters.
July 01, 2005
|
BiMo FOIA log.(Bioresearch Monitoring)(Freedom of Information Act)
July 01, 2005
|
PhRMA sees uploading all trial data since 2002 by September, but value...
July 01, 2005
|
Attorney advises omitting 'costs' in trial contracts to lessen chance ...
July 01, 2005
|
Pharma firms need to get hip to HIPAA, particularly concerning CROs an...
July 01, 2005
|
Lepay says warning letter for e-records violations not sign of more Pa...
July 01, 2005
|
Aman cited for research changes unapproved by IRB, failure to prepare ...
July 01, 2005
|
Londborg slapped with 1-item 483 for improper interviewing of subjects...
July 01, 2005
|
Warning letters.(inspection of pharmaceutical industry)
June 01, 2005
|
Attitudinal segmentation helps learn subjects' attitudes and needs, in...
June 01, 2005
|
Sponsor-investigators should have outsider monitor studies, even a sta...
June 01, 2005
|
CI receives 3-item 483 for adverse events, patient enrollment.(Clinica...
June 01, 2005
|
IRB Determination Letters.
June 01, 2005
|
BiMo FOIA log.(Freedom of Information Act)(Bioresearch Monitoring)
June 01, 2005
|
OHRP director says HHS considering guidance on CI training.(Clinical i...
June 01, 2005
|
HHS issues calls for proposals for 'electronic health record' system.(...
June 01, 2005
|
Trial delays tied to high drop-out rates; outreach boosts participatio...
June 01, 2005
|
MDS Pharma Services slapped with 3-item 483 concerning contamination f...
June 01, 2005
|
| |
1
