RA/QA News Roll: Mid January 2026
Here's what's happening at FDA and across the broader life science RA/QA space.
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This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
FDA Leadership and Administration
New telework policies restrict remote work — Inside sources report that the FDA announced revised Telework Program Policy prohibiting remote work except for Commissioner-approved exceptions, limiting staff to telework “at least one day per pay period at an approved Alternate Duty Station.” The policy reportedly returns the agency to “pre-Covid telework levels” and appears more restrictive than current CDER and CBER arrangements, raising concerns about staff retention and hiring efforts.
Commissioner faces potential congressional rebuke over Mifepristone 💊 — The Senate HELP Committee held a January 14 hearing titled “Protecting Women: Exposing the Dangers of Chemical Abortion Drugs” following reports that the FDA was “slow walking” promised mifepristone safety review. The hearing could put significant pressure on Commissioner Makary, whose agency recently approved another generic mifepristone, with some antiabortion groups already calling for his termination.
Prasad demands calendar transparency from CBER staff 💊 — CBER Director Vinay Prasad asked staff to ensure calendars are visible to him for direct meeting scheduling while keeping junior-level staff meetings secret from supervisors, according to an internal email reported by STAT News. The unusual request reflects ongoing management style concerns across FDA leadership.
HHS guidance portal frozen since September — The HHS guidance portal required under White House executive order hasn’t been updated since September 24, missing an entire quarter of guidance documents released during and after the government shutdown, hampering transparency efforts.
FDA General
QMSR implementation meeting held 💉 — With February 2, 2026, deadline approaching, FDA scheduled a January 14 meeting on “risk and design development” under the new Quality Management System Regulation, replacing the existing Quality System Regulation. We wrote about it here.
Mixed vaccine messages confuse Merck on Gardasil dosing 💊 — FDA sent conflicting signals about HPV vaccine Gardasil after CDC changed recommended schedule to single dose. Merck previously received FDA feedback that a single dose “may be less effective,” requiring “substantial evidence” through clinical trials, contradicting the FDA/CDC report stating “vaccination with one dose is as or nearly as effective as two doses.”
Vaccine safety report calls for chronic condition studies 💊 — A new FDA/CDC report co-authored by CDER Acting Director Tracy Beth Høeg calls for evaluating vaccination schedule impacts on “chronic conditions such as asthma, allergies, auto-immune diseases, developmental disorders (including ADHD, developmental delay, learning disabilities, intellectual disabilities, speech disorders, and tics), neurological disorders, seizures, diabetes, fertility issues, and eczema.”
COVID vaccine death data remains unpublished 💊 — Despite FDA pledge to release report on 10 pediatric deaths allegedly caused by COVID-19 vaccines by the end of December 2025, agency missed self-imposed deadline with no explanation for delay.
Clinical Decision Support guidance adds flexibilities 💉 — FDA finalized guidance loosening requirements for CDS tools, allowing more products to include risk scoring while maintaining clinical decision-making transparency requirements.
Bayesian methodologies guidance finally released 💊 — After a two-month delay following White House clearance, the FDA published draft guidance on using Bayesian statistical methods to support adaptive trial designs and borrow strength from prior research for drug effectiveness and safety determinations.
Cell and gene therapy manufacturing flexibility emphasized 💊 — FDA announced broader application of chemistry, manufacturing, and control (CMC) flexibilities previously used on a case-by-case basis for cell and gene therapy products, aiming to expedite development through more standardized regulatory accommodations.
STAR pilot program essentially deemed failure 💊 — An FDA assessment reveals the Split Real Time Application Review pilot attracted only six requests, with five failing criteria and one withdrawn, preventing comprehensive program evaluation. The agency and industry indicate the program is unlikely to continue in the next PDUFA reauthorization, effectively replaced by the Commissioner’s National Priority Voucher program.
GLP-1 suicide warnings to be removed 💊 — FDA requested manufacturers remove warnings about elevated suicide risk from Saxenda, Wegovy and Zepbound labels after agency evaluation “did not identify an increased risk” of suicidal behavior and ideation.
Rare Disease Day returns after cancellation — FDA’s 2026 Rare Disease Day meeting scheduled with an agenda focused on drug, biologic and medical device development, featuring top regulatory officials after the 2025 cancellation during organizational changes.
CBER releases ambitious 2026 guidance agenda 💊 — The Center for Biologics published a 35-document guidance agenda, considerably longer than the 2025 agenda, including notable titles on vaccine development and cell/gene therapy products.
Compliance and Enforcement
FDA issues flu vaccine febrile seizure warning letters 💊 — The agency sent six letters (one, two, three, four, five, six) to influenza vaccine manufacturers requiring label updates based on Biologics Effectiveness and Safety System data showing “increased risk of febrile seizures” shortly after vaccination.
Microsoft Teams background triggers warning 💊 — BeOne Medicine received an Untitled Letter for the proposed Teams background promoting Tevimbra without risk information, marking unusual enforcement action against virtual meeting promotional materials.
