These guidance documents should provide greater reassurance to digital product developers about how and when FDA will classify and regulate their products.
One of the first lessons I learned taking an economics class was the law of unintended consequences. The law seems to hold true time and time again. Case in point: The Right-To-Try (RTT) legislation recently passed by the House and Senate and signed into law by President Trump.
The passing of the Right to Try Act came after years of debate among politicians, the pharmaceutical industry, and other stakeholders about the potential legal, ethical, regulatory, and business impacts of RTT. That debate is unlikely to end any time soon.
Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.
DIA’s Conference on clinical trial endpoints will bring together key stakeholders to address critical questions and generate potential solutions to challenges associated with determining study endpoints and outcomes.
The Combination Products Conference will examine the recent and ongoing changes in the regulatory ecosystem for combination product development and approval.
Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
Contracting an in-country clinical depot helps bring costs and timelines under control.
Long-standing global relationship and history of quality important factors in selecting their partner to process foreign cases for PMDA submission for studies.
Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced its operating results for the first quarter of 2013.
Oracle and Proteus Digital Health announced recently that Oracle has made a strategic minority investment in Proteus, a leading digital health company.
NextDocs announced the release of NextDocs 6, the latest version of its award-winning regulated content management and compliance suite.
TransPerfect, a leading provider of solutions for global development and commercialization of products to the life sciences industry, announced that Aptalis Pharma ("Aptalis") has implemented Trial Interactive as its global pharmacovigilance system master file (PSMF) solution.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical™ technologies and delivering related services for the clinical trials industry, today announced its operating results for the fourth quarter and full year of 2012.
CFS Clinical (CFS), a specialty provider focused on the business and financial management activities for clinical trials, recently announced the launch of its upgraded technology platform and new tax consulting services.
Mesoblast Limited (ASX:MSB) (OTC ADR:MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility.
CRF Health, the developer of the TrialMax® Suite of electronic Clinical Outcome Assessment Solutions (eCOA) for the life sciences industry, becomes the first eCOA company to complete a full validation study for Professor Juniper’s ACQ and AQLQ questionnaires to the “Gold Standard” based on her recently released “Levels of Acceptability of Electronic Versions” rating system.
DATATRAK International, Inc. (OTCQX: DATA), a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced it will soon be trading as DTRK.
Mission3, the Premier Regulatory Information Management provider for the Life Science industry will be exhibiting at the upcoming 2012 RAPS – The Regulatory Convergence Conference. The company will have a booth set up in the exhibit hall (#224) and have team members attending the educational sessions.
Bioanalytical and pharmacokinetic specialty Contract Research Organization (CRO) MicroConstants announced today the successful completion of a five-day inspection by the United States Food and Drug Administration (FDA) for compliance with Good Laboratory Practice (GLP) regulations.
Merge Healthcare Incorporated, a leading provider of clinical systems and innovations that seek to transform healthcare, recently announced that Datapharm Australia Pty Ltd. has selected Merge’s eClinical OS™ solution to bring EDC in-house and provide control of electronic case report form (eCRF) creation and mid-study adjustments.
Five executives representing regional and national companies will receive Star Developer awards in recognition of their work to develop future leaders. The awards will be presented in October by The Professional Development Group, an executive coaching firm.