Recent changes
GovPing monitors 142 sources for this role across Guidance, Enforcement, Rule, Notice, and Consultation, out of 2,503 total sources on the platform. The past week saw 602 changes across these sources.
FDA issued a Warning Letter to Purolea Cosmetics Lab for CGMP violations, while also warning Dry Springs Pharmacy for unlawful opioid sales. A Class I recall of Philips Trilogy Evo ventilators highlights a serious device safety issue. The Class I recall of Draeger Atlan A350 anesthesia workstations further underscores critical equipment risks.
Elite Treats Recalls Chicken Chips for Salmonella Contamination
Elite Treats, LLC. is recalling a single lot of chicken dog treats due to potential Salmonella contamination. The recall impacts products sold to feed stores in Alabama, Florida, Georgia, North Carolina, and South Carolina. No illnesses have been reported to date.
Lockout Supplements Recalls Chocolate Syrup for Undeclared Sildenafil
Lockout Supplements is voluntarily recalling all lots of Boner Bears Chocolate Syrup nationwide due to undeclared sildenafil. The undeclared ingredient poses a risk of dangerous blood pressure reduction when interacting with prescribed medications.
EMA Recommends Six New Medicines for Approval
The European Medicines Agency's CHMP has recommended six new medicines for marketing authorisation and nine for extension of therapeutic indications. These recommendations cover treatments for various conditions including menopausal symptoms, liver disease, a rare genetic disorder, influenza, and graft-versus-host disease.
EMA Recommends Kygevvi for Rare TK2d Disease Treatment
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Kygevvi, a new treatment for the rare genetic disease thymidine kinase 2 deficiency (TK2d). This recommendation is based on clinical study data showing improvement in motor function for pediatric patients.
EMA Recommends Withdrawal of Levamisole Medicines
The European Medicines Agency (EMA) recommends the withdrawal of marketing authorisations for medicines containing levamisole due to the serious side effect of leukoencephalopathy. This recommendation follows an EU-wide review concluding that the benefits of these medicines no longer outweigh their risks for treating parasitic worm infections.
Levamisole withdrawn from EU market due to leukoencephalopathy risk
The EMA's PRAC has recommended the withdrawal of marketing authorisations for all medicines containing levamisole from the EU market. This decision is due to the confirmed risk of leukoencephalopathy, a serious brain side effect, where the benefits of the medicine no longer outweigh the risks for treating parasitic worm infections.
CVMP Opinions and Guidelines Update
The EMA's Committee for Veterinary Medicinal Products (CVMP) adopted positive opinions for several variations to existing veterinary medicinal products and discussed pharmacovigilance signals. These updates primarily involve product information changes based on signal management processes.
MHRA Raids Illegal Weight Loss Medicine Facility
The MHRA has raided two facilities suspected of manufacturing and selling illegal weight loss medicines, seizing nearly 2,000 doses and manufacturing equipment. This action is part of an ongoing investigation into a criminal network and aims to protect the public from dangerous, unregulated products.
MHRA Alert: Fake Mounjaro (tirzepatide) KwikPens
The MHRA has issued a notice regarding fake Mounjaro (tirzepatide) 15mg KwikPens dispensed by The Private Pharmacy Clinic in Birmingham. Patients with affected pens are advised to stop use immediately and report to the MHRA. The manufacturer reported five faulty pens.
MHRA Approves Imlunestrant Tosylate for Breast Cancer
The MHRA has approved imlunestrant tosylate (Inluriyo), a new treatment for adult patients with a specific type of advanced or metastatic breast cancer. This approval provides a new therapeutic option for patients who have not responded to prior hormonal treatment.
Get daily alerts for pharma & life sciences
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
601 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.
Who is this for?
Regulatory affairs professionals, pharmacovigilance teams, and medical affairs groups at pharma companies and CROs who need to track FDA and EMA actions.
How often is this updated?
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.
How is this different from AgencyIQ?
AgencyIQ is a full FDA intelligence platform. GovPing is a free feed of the FDA, EMA, and ICH source pages where warning letters, approvals, drug shortages, and guidance are first published - AI-summarized with attention-level ratings on every change.
Is GovPing free?
Yes. GovPing is free, and always will be. We believe government regulatory data should be accessible to everyone. For custom monitoring of pages we don't cover yet, Changeflow starts at $99/mo.
Need to monitor something else?
GovPing covers the common sources. For niche pages specific to your team, add custom URL monitoring with Changeflow.
Get Pharma & Life Sciences alerts
Daily digest of pharma & life sciences regulatory changes. AI-summarized, no noise.
Free. Unsubscribe anytime.