pharmaphorum
JANUARY 18, 2021
The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. The post A collaborative approach to greater diversity in clinical trials appeared first on.
Advarra
MARCH 21, 2023
Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?
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pharmaphorum
DECEMBER 1, 2022
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.
pharmaphorum
MAY 14, 2021
Kintor posted a press release at the end of April to announce that phase 3 clinical development had begun and since then it has seen its share price rise considerably on the Hong Kong stock exchange. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.
Drug Discovery World
NOVEMBER 3, 2023
News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.
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. §
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). 42 U.S.C. §
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