FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52

FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a).

Clinical Trials 40

Clinical Trials Clinical Trials Trials Regulation 40

XTalks

APRIL 26, 2021

Related: After 18 Years, FDA Approves Malaria Prevention Drug. Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa.

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Vaccination Vaccine Immune Response Trials 105

Delveinsight

AUGUST 12, 2021

The two-year-old Canadian biotech will utilize series A to bring a lineup of SGK1 inhibitors through phase 1 clinical studies. LQTT has a portfolio of in-licensed compounds from Sanofi that prohibit serum/glucocorticoid-regulated kinase 1, or SGK1. Sage Partner and existing backers also participated.

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Trials Clinical Trials Clinical Trials Regulation 97

Placebo Control

JULY 31, 2013

Ben Goldacre has rather famously described the clinical trial reporting requirements in the Food and Drug Administration Amendments Act of 2007 as a “ fake fix ” that was being thoroughly “ignored” by the pharmaceutical industry. Pharma: breaking the law in broad daylight?

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Pharma Companies Trials Compliance Clinical Trials 40