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.
AstraZeneca studies nurandociguat drug interactions with rosuvastatin, dabigatran
AstraZeneca registered a Phase I clinical trial on ClinicalTrials.gov investigating potential drug interactions between nurandociguat and two established medications—rosuvastatin (a statin) and dabigatran (an anticoagulant). The single-arm study will evaluate pharmacokinetic parameters in healthy participants to assess how co-administration affects drug exposure and safety profiles.
NX-5948 versus pirtobrutinib relapsed refractory CLL SLL trial
ClinicalTrials.gov registered a new Phase 3 randomized trial (NCT07516093) comparing NX-5948 to pirtobrutinib in adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The single-arm study will evaluate efficacy and safety endpoints.
ASP Data Submission Notice for Medicare Part B Drugs - Comments Closed May 7
CMS published a 30-day Paperwork Reduction Act notice announcing revision of an existing collection for manufacturer submission of Average Sales Price (ASP) data for Medicare Part B drugs and biologicals. The notice revises the Bona Fide Service Fee Certification form and updates burden estimates. Comments on the information collection must be received by the OMB desk officer by May 7, 2026.
CMS Proposes Skilled Nursing Facilities Payment Updates for FY 2027
CMS has published a proposed rule (CMS-1843-P) updating the Skilled Nursing Facility Prospective Payment System rates and policies for fiscal year 2027. The rule also proposes updates to the SNF Quality Reporting Program and SNF Value-Based Purchasing Program requirements. Comments must be submitted by June 1, 2026.
Medicare Prior Authorization WISeR Model Correction Notice
CMS issued a correction notice to fix typographical and technical errors in the July 1, 2025 Federal Register notice about the WISeR (Wasteful and Inappropriate Services Reduction) Model for Medicare prior authorization. The corrections update specific lists of procedure codes for epidural steroid injections, vertebral compression fracture procedures, fusion procedures, and apnea treatments, while also clarifying applicability language for skin and tissue substitutes. The corrections are effective April 6, 2026, with applicability to January 1, 2026.
Medline Convenience Kits containing Namic RA Syringes recall - death risk
Health Canada issued a Type I recall for Medline Convenience Kits containing Namic RA Syringes due to a potential risk of the syringe rotating adaptor unwinding during use, which may cause procedural delays or, in severe cases, death. Multiple lot numbers across angiographic kits, convenience kits, and tumescent syringe kits are affected. Healthcare providers have been advised to immediately stop using and discard the affected syringes.
Adaptive proton therapy pediatric solid tumors Hodgkin's lymphoma
ClinicalTrials.gov registered a new Phase 2 interventional study (NCT07514819) evaluating adaptive proton therapy for pediatric patients with solid tumors and Hodgkin's lymphoma. The single-arm trial will assess treatment response rates, survival outcomes, and treatment-related toxicity in pediatric oncology patients. The study is sponsored by the University of Pennsylvania and will enroll approximately 40 participants.
MR-guided adaptive stereotactic radiotherapy for endometrial cancer, Radboud University
The National Library of Medicine registered a new clinical trial (NCT07514325) on ClinicalTrials.gov studying MR-guided adaptive stereotactic radiotherapy for endometrial cancer. The single-arm study will enroll an estimated 20 participants at Radboud University Medical Center in the Netherlands to evaluate feasibility and toxicity outcomes of adaptive radiotherapy guided by MRI imaging.
Pulsed Tm:YAG vs Holmium laser kidney stone trial, NYU Langone Health
NYU Langone Health registered a new clinical trial (NCT07516106) on ClinicalTrials.gov comparing pulsed Tm:YAG laser versus Holmium laser for kidney stone treatment. The single-center randomized study will enroll approximately 100 participants and is sponsored by NYU Langone Health. The trial appears to be recruiting.
QL1706 bispecific antibody neoadjuvant trial, not recruiting
The National Library of Medicine updated ClinicalTrials.gov trial record NCT07515469 for QL1706, a bispecific antibody, to reflect a change in recruitment status from recruiting to not recruiting in a neoadjuvant treatment setting. The trial, which evaluates QL1706 as a bispecific antibody therapeutic, has modified its enrollment status. No specific enrollment numbers or timeline changes were provided in the status update.
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661 changes in last 7 days
Latest high priority updates
142 official sources tracked
Frequently asked questions
What does this feed cover?
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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Regulatory affairs professionals, pharmacovigilance teams, and medical affairs groups at pharma companies and CROs who need to track FDA and EMA actions.
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GovPing checks source pages multiple times daily. FDA warning letters and drug approvals typically appear within hours of publication.
Does this cover EMA and international regulators?
Yes. We monitor the EMA, ICH, WHO, TGA (Australia), and other international health authorities alongside FDA.
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