News

After legislation signed by President Joe Biden, U.S. Food and Drug Administration (FDA) will not require animal tests before human drug trials. This is applicable to drugs and biologicals.

Turkish Clinical Research Association wishes a happy and healthy 2022 without COVID-19...

The European Union’s Health Commission proposed pushing back the deadline for the new medical device regulation (MDR) law to 2028. The deadline for high-risk products will be 2027. and a 2028 deadline for medium and low-risk devices is proposed.

Articles co-authored by Nobel-prizewinning geneticist Gregg Semenza are under concern after the comments on the website PubPeer about the integrity of images in the papers.

As the number of endpoints analyzed in a single trial increases, the likelihood of making false conclusions about a drug’s effects with respect to one or more of those endpoints becomes a concern if there is not appropriate adjustment for multiplicity. The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well-recognized statistical methods for managing multiplicity within a study in order to control the chance of making erroneous conclusions about a drug’s effects.

The WHO issued an alert over four cough syrup-based products manufactured by Maiden Pharmaceuticals from India. There are 66 reported children deaths.

This qualification is the first time a regulatory body has formally supported a machine learning-based method for reducing sample size in Phase II or III trials.

FDA issued a Draft Guidance that aims to protect Children who participate in Clinical Trials. To read the draft click here...

FDA revises draft guidance on pediatric clinical pharmacology studies...

This draft guidance will be an update for the 2016 guidance with the same title