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.
Complaint Regarding Potential Regulatory Violation
FDA posted a complaint under docket FDA-2026-H-3081-0001 on April 3, 2026. The complaint, authored by CTP (Center for Tobacco Products), relates to a potential regulatory violation. No documents are currently available for review on regulations.gov.
Variance Application from BF Light Shows, Michigan
FDA CDRH received a variance application from BF Light Shows, a Michigan-based entity, seeking regulatory relief or alternative compliance pathway under FDA electronic product radiation control requirements. The application was filed under docket FDA-2026-V-2878.
VYLOY Patent Extension Regulatory Review Period Determination
The FDA has determined the regulatory review period for VYLOY, a human biological product, and published this notice as required under 35 U.S.C. 156. The notice invites comments on whether any published dates are incorrect by June 2, 2026, and allows interested persons to petition FDA regarding due diligence by September 30, 2026.
Customer Service Satisfaction Surveys - PRA Comment Request
The FDA is seeking public comments on proposed customer service satisfaction surveys under the Paperwork Reduction Act of 1995. The 60-day comment period closes June 2, 2026. This is a routine information collection request; no new burdens are proposed as it involves existing customer service survey collections.
Determination of Regulatory Review Period for VYLOY Patent Extension
FDA has determined the regulatory review period for VYLOY, a human biological product, as required by law for patent extension purposes. The Agency is publishing this notice to allow interested parties to comment on the determination or petition for redetermination regarding due diligence. Multiple patent extension applications (FDA-2025-E-0845 through FDA-2025-E-0872) are included in this notice.
VYLOY Regulatory Review Period Determination for Patent Extension
The FDA has determined the regulatory review period for VYLOY, a human biological product, as required by law for patent extension purposes. The notice solicits public comments on the accuracy of the published dates and allows interested parties to petition FDA regarding whether the applicant acted with due diligence during the review period. Comments on date accuracy are due June 2, 2026, and due diligence petitions are due September 30, 2026.
FDA reviews patent extension for cancer drug VYLOY
FDA reviews patent extension for cancer drug VYLOY
Tobacco Product Citizen Complaint
FDA Center for Tobacco Products received and closed a citizen complaint (FDA-2026-H-3165) for comments. The complaint is now in closed status with no documents available for public review. No regulatory action or compliance requirements identified.
FDA Complaint Filed with Center for Tobacco Products
FDA Center for Tobacco Products filed a complaint under docket FDA-2026-H-3164-0001. The complaint has been closed for comments, indicating the administrative filing process is complete. No documents are available for public review at this time.
EMRELIS Patent Extension Regulatory Review Period Determination
FDA has determined the regulatory review period for EMRELIS, a human biological product, for purposes of patent extension under federal law. The notice opens a public comment period until June 2, 2026, and allows interested parties to petition FDA regarding the applicant's due diligence by September 30, 2026. This determination affects the calculation of any patent term extension.
Get daily alerts for pharma & life sciences
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
558 changes in last 7 days
Latest high priority updates
139 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.