Category: Diagnostics

Procedural Aspects for the Consultation to the European Medicines Agency by a Notified Body on Companion Diagnostics

December 31, 2021
Diagnostics

The guidance document aims to provide interested parties in particular notified bodies, device manufacturers, and medicinal product applicants, with appropriate guidance on procedural aspects to facilitate...

Body on Companion Diagnostics, eu medical device regulations, eu medicines agency, Notified Body on Companion Diagnostics

Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products – FDA Draft Guidance

December 11, 2021
Diagnostics

Use of Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products FDA issued the draft guidance as part of its Real World Evidence (RWE) Program...

Drug and Biological Products, FDA Draft Guidance, Real-World Data, Real-World Evidence

WHO Recommendations for screening and treatment to prevent cervical cancer

November 5, 2021
Diagnostics

Too many women worldwide – particularly the poorest women – continue to die from cervical cancer; a disease that is both preventable and treatable. In order to help countries make faster progress,...

cervical cancer, cervical cancer prevention, cervical cancer screening guidelines, Guidelines for cervical cancer prevention., prevent cervical cancer, Recommendations cervical cancer prevention, strategy for cervical cancer prevention

Clinical Intelligence for better Clinical Trials

January 29, 2021
Diagnostics

Every sector including healthcare is based on data nowadays. The only issue with healthcare is the complexity of the clinical data. The constant regulatory changes added with the rising competitions...

Clinical Intelligence, Clinical Intelligence in Clinical Trials, Role of Clinical Intelligence:

Australia: TGA Implemented the Risk-Based Approach Surrounding Fecal Microbiota Transplants

September 27, 2019
Diagnostics

The Australian Therapeutic Goods Administration (TGA) has adopted a risk-based approach that’s applicable to the Fecal Microbiota Transplants (FMT). The TGA had earlier decided that all the FMT...