Food and Drug Administration · Notice
5 days leftPublished Aug 5, 2026 · Comments close Nov 3, 2026
FDA CDER wants input on building a Quantitative Medicine Innovation Network that would speed quantitative methods into drug development and review.
Who it hits Drug developers, quantitative modelers, academic centers, and software vendors working on model-informed drug development.
Food and Drug Administration · Notice
11 days leftPublished Sep 24, 2026 · Comments close Nov 9, 2026
HHS is asking how deceased-donor islet cells for Type 1 diabetes should be regulated, including whether unmodified isolates should be treated differently from modified products.
Who it hits Cell therapy sponsors, transplant programs, diabetes clinics, and islet processing labs.
Food and Drug Administration · Notice
12 days leftPublished Sep 11, 2026 · Comments close Nov 10, 2026
FDA is renewing the paperwork package behind medical device tracking and wants comments on the information it collects from manufacturers.
Who it hits Device makers that ship trackable implants or life-supporting devices, and their quality or regulatory teams.
Food and Drug Administration · Notice
19 days leftPublished Sep 18, 2026 · Comments close Nov 17, 2026
FDA published draft guidance on an electronic submission template for medical device PMA applications to CDRH and CBER.
Who it hits PMA sponsors, eCopy and eSTAR vendors, and regulatory consultants who prepare Class III device filings.
Centers for Medicare & Medicaid Services · Notice
22 days leftPublished Oct 21, 2026 · Comments close Nov 20, 2026
CMS proposes a computer matching program with the VA to find people enrolled in both Medicare and VHA care and to spot dual-paid claims.
Who it hits Medicare and VA claims processors, health IT vendors supporting dual-eligible workflows, and privacy officers.
Centers for Disease Control and Prevention · Notice
22 days leftPublished Sep 21, 2026 · Comments close Nov 20, 2026
CDC wants public input on how data intermediaries can support secure, standards-based public health data exchange at scale.
Who it hits HIEs, EHR vendors, public health agencies, and companies that move clinical data into surveillance systems.
Centers for Medicare & Medicaid Services · Proposed Rule
25 days leftPublished Sep 24, 2026 · Comments close Nov 23, 2026
CMS is gathering input on what counts as reasonable and relevant pharmacy contract terms for Medicare Part D any-willing-pharmacy rules.
Who it hits Part D plans, PBMs, independent and chain pharmacies, and pharmacy contracting platforms.
Food and Drug Administration · Notice
29 days leftPublished Oct 28, 2026 · Comments close Nov 27, 2026
FDA draft guidance explains when multiple variants of an individualized human genome-editing product can sit in one BLA, and how to manage them after approval.
Who it hits Gene-editing sponsors, advanced therapy manufacturers, and BLA regulatory teams.
Centers for Medicare & Medicaid Services · Notice
32 days leftPublished Oct 29, 2026 · Comments close Nov 30, 2026
CMS proposes a matching program with state-based administering entities to check eligibility for ACA state health subsidy programs.
Who it hits State exchanges, eligibility vendors, Medicaid agencies, and consumer enrollment platforms.
Centers for Medicare & Medicaid Services · Proposed Rule
39 days leftPublished Oct 8, 2026 · Comments close Dec 7, 2026
CMS proposes CLIA updates that would allow virtual access under a primary lab's certificate (except cytology) and digital images for gynecologic cytology proficiency testing, plus personnel and SARS-CoV-2 reporting changes.
Who it hits Clinical labs, digital pathology vendors, remote-read networks, and lab accreditation consultants.
Centers for Medicare & Medicaid Services · Proposed Rule
47 days leftPublished Oct 20, 2026 · Comments close Dec 15, 2026
CMS proposes rules to implement CAA 2026 sections on Part D low-income cost sharing, a REAL Health Providers provider-list requirement, and stronger PBM accountability.
Who it hits Part D plans, PBMs, provider directory vendors, and Medicare Advantage operations teams.
Food and Drug Administration · Notice
60 days leftPublished Oct 28, 2026 · Comments close Dec 28, 2026
FDA draft guidance introduces an electronic submission template for Investigational Device Exemption applications to CDRH and CBER.
Who it hits IDE sponsors, clinical research orgs running device trials, and eSTAR or eCopy tooling vendors.