Recent changes
GovPing tracks 141 sources for this role out of 2,348 total sources on GovPing, covering Guidance, Enforcement, Rule, Notice, and Consultation instruments. There were 722 changes in the last 7 days.
Health Canada issued a Type I recall for nitrous oxide chargers sold by DOODELZ, Gold Whip, and Whip-it! brands without market authorization, while the UK VMD called for a Class II recall of Zoetis's Scabigard Suspension for cutaneous administration. FDA classified Draeger's Atlan A350 anesthesia workstations as a Class I recall due to potential piston ventilator failure, and Morovan recalled approximately 4,000 units of Gel Nail Polish Remover for methylene chloride and chloroform contamination.
NICE Guidance: Pegzilarginase for Arginase-1 Deficiency
NICE has published guidance recommending pegzilarginase (Loargys) for treating arginase-1 deficiency in individuals aged 2 years and over. The guidance includes evidence-based recommendations and details a commercial access agreement for the treatment.
NICE Guidance: Leniolisib for PI3K delta syndrome
NICE has published highly specialised technologies guidance on the use of leniolisib (Joenja) for treating activated phosphoinositide 3-kinase delta syndrome in individuals aged 12 and over. The guidance includes evidence-based recommendations and information on commercial arrangements for NHS organisations.
NICE Guidance: Durvalumab for Muscle-Invasive Bladder Cancer
NICE has published technology appraisal guidance (TA1138) recommending durvalumab with gemcitabine and cisplatin for the neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer. The guidance includes information on commercial arrangements and reporting adverse events.
NICE Guidance: Epcoritamab for Follicular Lymphoma
NICE has published technology appraisal guidance (TA1139) recommending epcoritamab (Tepkinly) for treating relapsed or refractory follicular lymphoma in adults after two or more lines of systemic treatment. The guidance outlines evidence-based recommendations for healthcare professionals.
Baloxavir marboxil appraisal terminated for children
NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.
NICE Guidance on Bevacizumab for Metastatic Colorectal Cancer (TA1136)
NICE has published updated technology appraisal guidance (TA1136) on the use of bevacizumab (originator and biosimilars) with fluoropyrimidine-based chemotherapy for metastatic colorectal cancer. This guidance replaces previous recommendations and provides evidence-based recommendations for healthcare professionals.
Canagliflozin Appraisal Terminated for Type 2 Diabetes in Youth
NICE has terminated the appraisal of canagliflozin (Invokana) for treating type 2 diabetes in individuals aged 10 to 17 years. The appraisal was terminated because the company failed to provide an evidence submission. NICE will review this decision if a submission is made.
Carbachol Monograph Revision - Assay Criteria
The United States Pharmacopeia (USP) is revising the Carbachol monograph to widen the acceptance criteria for Assay from NMT 99.0%-101.0% to NMT 98.0%-102.0%. This change aims to accommodate FDA-approved products with wider specifications and is targeted for publication on May 29, 2026, with an official date of June 1, 2026.
Adapalene Monograph Revision Proposed for Solubility Issue
The USP Small Molecules 3 Expert Committee intends to revise the Adapalene monograph to address a potential solubility issue in the Organic Impurities test. The proposed changes include allowing a larger volume of tetrahydrofuran for the standard stock solution, introducing a two-table format for retention times, and deleting the Limit of Triethylamine test.
USP Notice: Revision to Sennosides Tablets Monograph Testing Method
The USP has issued a Notice of Intent to Revise the Sennosides Tablets monograph testing method. This revision aims to align the testing procedure with recent changes made to the general sennosides monograph, using sennosides A and B as marker compounds. The targeted official date for this revision is August 1, 2027.
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737 changes in last 7 days
Latest high priority updates
142 official sources tracked
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FDA warning letters, novel drug approvals, drug shortage notices, ICH guideline updates, USP notices, EMA news, DEA scheduling decisions, and TGA/WHO standards.
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