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Home » Topics » Clinical Trials » Data Integrity

Data Integrity
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FDA Invites Comments on Clinical Data Template

December 18, 2017
The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials. Read More

FDA Guidance on Device Trial Demographics Targets Transparency, Data Consistency

November 16, 2017
New medical device clinical trial guidance aims to improve participation diversity and increase data consistency and transparency, FDA officials said in an Oct. 31 webinar. Read More

FDA Invites Comments on Clinical Data Template

November 9, 2017
The agency will review the proposed template. Read More

FDA Invites Comments on Clinical Data Template

November 7, 2017
The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials. Read More

FDA Sends Warning Letters to CIs for Deviating from Protocols

April 13, 2016
The FDA has issued warning letters to two clinical investigators who deviated from their investigational plans. Read More

FDA Sends Warning Letters to CIs for Deviating from Protocols

April 7, 2016
The FDA has taken two clinical investigators to task for deviating from their investigational plans. Read More

EMA Clarifies Clinical Requirements for Fixed-Dose Combination Drugs

June 12, 2015
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More

Pediatric Disease Voucher Worth $245 Million to Sanofi

June 11, 2015
French drug giant Sanofi will spend $245 million to acquire San Diego-based Retrophin’s rare pediatric disease priority review voucher. Read More

EMA Confirms Suspension of Drugs Over Flawed Studies

June 11, 2015
The European Medicines Agency has confirmed plans to halt sales of 700 drug forms and strengths authorized based on clinical studies performed by Hyderabad, India-based GVK Biosciences. Read More

Chinese Device Trial Guidelines Exempt ‘Equivalent’ Products

June 11, 2015
Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, the Chinese regulators say. Read More

CXL-USA Warned Over Unapproved Clinical Trial

June 11, 2015
The FDA issued Rockville, Md.-based CXL-USA a warning letter for failing to get agency approval before starting a clinical trial and for lax monitoring of the study. Read More

Pediatric Extrapolation Guidance Applies to New, Existing Devices

June 11, 2015
New guidance on extrapolating existing data to gain approval for pediatric indications applies to new devices as well as those already approved for adult use, an FDA official says. Read More
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