Search Results for clinical trial regulations

Showing 1 – 4

EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations By Zachary Brennan - Published 23 May 2017

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: News, Europe, EMA, Clinical, Compliance, Government affairs, Research and development

Tags: clinical trial regulations, EMA guideline

Petition to FDA Seeks to Modify Trial Regulations Following Deaths By Zachary Brennan - Published 18 May 2017

A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs).

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: citizen petition, FDA petition, clinical trial regulations

Brazilian Regulators Propose Amendments to Country's Clinical Trial Rules By Louise Zornoza, RegLink News - Published 08 August 2014

Brazil’s national regulatory agency, Anvisa, announced on 4 August 2014 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices.

Categories: News, Latin America and Caribbean, Anvisa, IMDRF, Clinical, Drugs, Medical Devices

Tags: Brazil, Clinical Trial Regulations, IMDRF

India Issues Final Rule on Compensating Clinical Trial Deaths By Louise Zornoza, RegLink Associates - Published 02 June 2014

India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be paid by clinical trial sponsors for the death of a clinical trial research subject. 

Categories: News, India, CDSCO, Clinical, Ethics

Tags: Clinical Trial Regulations, Compensation, Clinical Trials