Guidance Documents

The proposed new EU guidance will focus on the regulatory and methodological aspects of clinical trial design and marketing authorization for tRPs, according to a concept paper that has just been issued for public consultation.

The US FDA has released its annual list of planned guidance documents for the upcoming fiscal year. While many topics on the list are familiar, a new “Under Construction” list shows rising priorities.

An examination of the global implementation of guidelines from the International Council for Harmonisation by regulators has yielded positive outcomes.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

The US FDA is finalizing a guidance intended to encourage the use of decentralized clinical trial techniques. After the COVID-19 pandemic necessitated adoption of the more patient-friendly approaches, the agency is clearly eager to see them become routine.

Industry organizations argued feedback should be expected and object to draft guidance language suggesting it may be optional. The agency also should apply waiver criteria flexibly and address potential consequences if enrollment goals are not met, stakeholders say.

New guidance from the European Medicines Agency explains how in vitro and in vivo models may be used instead of clinical data for the purpose of establishing therapeutic equivalence in a stepwise approach.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.

Guidance documents issued 30 September explain how makers of air powered dental handpieces and air motors, dental cements, dental ceramics, and dental impression materials can bring their products to market by demonstrating compliance with established criteria, without a direct comparison to a predicate device.