Topic

Jason Boyd is senior director, Veeva Vault LIMS.

Articles

Using one system for test execution and sample management, improving right-first-time, and allowing review by exception can deliver access to key lab data faster. 

Getting Lab Data Closer to the Decision Point Keeps Product Release on Track 

The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.

Endo Recalls Clonazepam Because of Mislabeling

PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.

EMA’s PRAC Offers Recommendations for Glucagon-like Peptide-1 Receptor Agonists and Glatiramer Acetate

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

Roche to Reintroduce nAMD Treatment in US After FDA Approves Updates

Kevin O’Donnell is Market Compliance Manager at Ireland’s Health Products Regulatory Authority.

Umit Kartoglu is president and CEO, Extensio et Progressio,
Collonge-Bellerive, Switzerland.

This paper reflects upon the past 15 years of experience in the application of QRM and KM within the pharmaceutical GMP environment. 

QRM, Knowledge Management, and the Importance of ICH Q9(R1)

Mike Hennessy Jr. is the President and CEO of 

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

Publisher's Note: With Age Comes Wisdom

Feliza Mirasol is the science editor for 

GSK’s application for using Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer has been accepted by the EMA.

GSK’s Application for Jemperli Plus Chemotherapy for Use in All Patients with Endometrial Cancer Accepted by EMA

Life sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.

Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory Context

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

NIPTE Strategy Aims to Mitigate US Pharma Supply Chain Risk

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

Quality Systems