On 13 August, President Donald Trump issued an executive order directing the Assistant Secretary for Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) to ...

The International Council for Harmonization (ICH) has released a draft Q3E guideline that offers a harmonized framework for assessing and controlling extractables and leachables (E&L) in ...

Event Description: Are you part of Alberta’s life sciences community? Do you work in regulatory affairs, quality, or clinical research (RA/QA/CA)? Then come join us for a casual evening of ...

The UK has set out plans to get new medicines to patients three to six months sooner by coordinating regulatory and reimbursement processes.

The US Food and Drug Administration (FDA) has finalized a guidance detailing its expectations for the clinical development of drugs to treat early Lyme disease. The final guidance includes several ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website(s) for each country@s ministry of health and regulatory authority. The list is ...

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...

The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book.

At what point does manipulation or repair of a medical device cross the line from @servicing@ to @remanufacturing?@ A new draft guidance from the US Food and Drug Administration (FDA) provides a set ...

The US Food and Drug Administration (FDA) on Monday finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.

To comply with a recent executive order, the US Food and Drug Administration (FDA) on Friday released a list of more than 300 essential drugs and medical devices that will serve as a basis for ...