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Real World Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products – FDA Draft Guidance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Data and Real World Evidence to Support Regulatory Decision Making for Drug and Biological Products FDA issued the draft guidance as part of its Real World Evidence (RWE) Program...

Drug and Biological Products, FDA Draft Guidance, Real-World Data, Real-World Evidence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

Serotonergic Anti-depressants for Depression in Pregnant Women

June 16, 2021
Diagnostics

New Zealand’s Medicines and Medical Devices Safety Authority (MEDSAFE) has published few takeaways pertaining to the new minimal risk of postpartum haemorrhage with the consumption of certain anti-depressants...

benefits of treating depression for mother, minimal risk of postpartum hemorrhage, new minimal risk of postpartum, Serotonergic Anti-depressants

Clinical Trial Management Guidelines under Covid-19 – Europe

June 9, 2021
Diagnostics

Good Clinical Practice (GCP) is referred to an internationally acclaimed ethical and scientific quality standard for designing, recording and reporting trials involving participation of human subjects....

clinical trial management, corona vaccine clinical trails, guidance covid vaccine trails, guidelines under covid-19 Europe, Managing clinical trials during COVID-19

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...