FDA’s new CSA guidance: transforming software validation for production and quality systems

FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.

Could an overly burdensome QMS be the organization’s own doing?

Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...

New version of ISO 10993-1: the core standard for the biological evaluation of medical devices

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...

A cluster contribution to European life science innovation and competitiveness?

The FDA’s new transparency policy (Part 3)

As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...

Del 3 av Advance serien: Design

Ta reda på hur du kan omvandla en audit till en konkret lösning. Spirax Sarcos designfas ger dig allt du behöver för att implementera ett optimerat och framtids...

3 000 ska bort från Australiens största läkemedelsbolag

Det australiensiska läkemedelsjätten CSL genomför sparåtgärder. I planen ingår bland annat att knoppa av bolagets vaccinenhet och minska arbetsstyrkan med 3 000 medarbetare.

Roche joins Medicon Village

Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...

Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”

Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...

FDA approves Gilead’s HIV injection: “Historic day”

Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...

Anocca raises SEK 440 million ahead of clinical cancer trial

Swedish cell therapy biotech Anocca has successfully raised SEK 440 million in a new funding round to support upcoming clinical trials in pancreatic cancer.

How the Nobel discovery is used in drug development

Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...

The New Precise Magazine is Available Now

Download the new issue.

The FDA’s new transparency policy (Part 2)

In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...

Many discontinue obesity medication – new study highlights the reasons

A new study maps out the most common reasons why patients choose to stop taking obesity medication prematurely. “Obesity medication discontinuation reverses hea...

In search of Marcel Proust's lost health

A great writer, but also a weak person and a hypochondriac. That has been the usual image of Marcel Proust. But the pediatrician and literary scholar Carl Lindg...

Pulsen på patientförbunden del 3: Reumatism

”Våra forskarkollegor har en vision om att reumatiska sjukdomar ska kunna förebyggas”, skriver Reumatikerförbundets ordförande Lotta Håkansson.

ZEISS unveils AI-powered Research Data Platform

Collaboration with Boehringer Ingelheim champions the future of personalized eye care.

Medical Plastics Tips & Tricks

Measuringhero video by ZEISS.

Avhopp i Kennedys vaccinkommitté inför första mötet

Efter att ha sparkat samtliga experter i USA:s vaccinkommitté och tillsatt åtta nya, står hälsominister Robert F. Kennedy Jr. nu med en ofullständig panel. En m...

Organize and Manage Digital Classrooms

Create engaging lessons with ZEISS Labscope Teacher.

Venomaid's rapid test aims to find the right snake bite treatment

Every six seconds, someone on our planet suffers a snake bite, and each time, a race against the clock begins. What kind of snake was it, and which antivenom can help? Danish company Venomaid Diagnostics is working hard to develop solutions to a problem...

RegSmart Life Science AB

New drug to simplify treatment of hemophilia

A new type of treatment for hemophilia, which only needs to be administered every two months, has been approved by the U.S. Food and Drug Administration (FDA).