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.
USP Notice: Revision to Guaifenesin, Pseudoephedrine HCL, Dextromethorphan Capsules Monograph
The United States Pharmacopeia (USP) has issued a notice of intent to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. The revision aims to update a cross-reference to an omitted monograph and incorporate the full text of a previously official assay procedure.
Dapagliflozin Tablets Monograph Revision Notice
The USP is issuing a notice of intent to revise the Dapagliflozin Tablets monograph, with a targeted official date of June 1, 2026. This revision is being made in response to comments received, aiming to incorporate feedback into the monograph.
Medicare.gov Enhanced Login Options
The Centers for Medicare & Medicaid Services (CMS) has introduced new login options for Medicare.gov, including ID.me, CLEAR, and Login.gov, to enhance user security and protect beneficiary information from fraud and identity theft. These services are free and offer various verification and support methods.
Crackdown on Health Care Fraud
The Trump Administration announced a major crackdown on health care fraud, including deferring $259.5 million in federal Medicaid funding to Minnesota and imposing a nationwide moratorium on Medicare enrollment for certain DMEPOS suppliers. The initiative aims to prevent fraud before it occurs and protect taxpayer dollars.
CMS Extends GENEROUS Model Application Deadline
The Centers for Medicare & Medicaid Services (CMS) has extended the application deadline for the GENEROUS Model, a drug pricing initiative for Medicaid, from March 31, 2026, to April 30, 2026. This extension provides additional time for prescription drug manufacturers to apply to participate in the model, which aims to lower drug spending and improve health outcomes.
HHS Proposed Rule for Health Insurance Exchanges 2027 Payment Parameters
HHS, through CMS, has issued a proposed rule outlining benefit and payment parameters for Health Insurance Exchanges for the 2027 plan year. The proposal includes changes to risk adjustment programs, user fees, marketing practices, and plan options, with a public comment deadline of March 13, 2026.
FDA Approves Filgrastim-LAHA Biosimilar
The FDA has approved FILKRI (filgrastim-LAHA), a biosimilar product, for ACCORD BIOPHARMA INC. The approval was granted on January 15, 2026, under Biologic License Application (BLA) 761027. This marks the addition of a new biosimilar option to the market.
FDA Approval of JUBEREQ and OSVYRTI (denosumab-desu)
The FDA has approved Biologic License Application (BLA) 761424 for JUBEREQ and OSVYRTI, both containing the active ingredient denosumab-desu, submitted by ACCORD BIOPHARMA INC. This approval marks the addition of new prescription injectable medications to the market.
FDA Approves ARMLUPEG (Pegfilgrastim-unne) Biosimilar
The FDA has approved ARMLUPEG (pegfilgrastim-unne), a biosimilar drug manufactured by LUPIN LTD. This approval marks the addition of a new biosimilar product to the market, following the FDA's review process.
FDA Approves Ranibizumab-leyk Biosimilar (NUFYMCO)
The FDA has approved the Biologic License Application (BLA) 761473 for NUFYMCO (ranibizumab-leyk) from FORMYCON AG. This approval marks the addition of a new biosimilar product to the market.
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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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