The U.S. Food and Drug Administration is “almost certain) to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, thought the question of how much data will be required is major factor in determining how quickly the U.S. biosimilars market will take off, according to a new report from the law firm Goodwin Proctor.
The new EU clinical trials regulation: what you need to know before 2016
New Draft Guidance on best practices for IND communications between sponsors, FDA
Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. (Regulatory Focus, Regulatory Affairs Professionals Society)
FDA authorizes first human study to use in vivo genome editing application
The US Food and Drug Administration (FDA) broke new ground last week when it authorized the world’s first human clinical trial for an in vivo genome editing application. The investigational new drug (IND) application approval for California-based Sangamo, which is the first and only company to put a gene editing therapy into clinical trials, allows the company to begin conducting in 2016 a Phase 1/2 open-label, dose-escalation study in up to nine male adults with severe hemophilia B. (Regulatory Focus, Regulatory Affairs Professionals Society)
New regulation will drive EU clinical trials, but are you ready for it?
The new EU clinical trial regulation will overhaul the sector according to SynteractHCR, but are CROs prepared for the extra resources and tighter deadlines it will produce?
U.S. plans to require trial consent publication
The U.S. government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human Services (HHS).
FDA seeks comments on mHealth in clinical trials
…In an October 29 notice published in the Federal Register, the FDA is seeking input on how mHealth technology might be used to improve clinical trials. The agency is particularly interested in how healthcare providers and other parties are using consumer-generated data, how they’re reaching out to consumers, and whether the data being collected is useful and reliable. (mHealthNews)
Learn from Theranos’s mistakes: an analysis of the Form 483s (Part 1)
Startups should heed the Theranos warning: When you raise millions of dollars to develop a product, remember the processes that help get that product to market, including proper implementation of a robust quality management system. (MDDI Online)
U.S. plans to require trial consent publication
The U.S. government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human services (HHS). (Outsourcing-Pharma.com)
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