TL;DR
The federal drug regulatory apparatus is executing a massive operational reset, launching an aggressive hiring campaign to recover from severe staff attrition while accelerating stalled clinical reviews. Under interim leadership, the FDA is rapidly pushing previously rejected therapies toward decisive summer advisory panels, signaling a collaborative shift to mend industry relationships. However, this regulatory flexibility will face immediate tests as highly anticipated therapies navigate both clinical scrutiny and complex commercial litigation.
The FDA's Post-Attrition Rebuilding Campaign
The federal drug regulatory apparatus is launching an aggressive stabilization campaign to recover from historic staffing losses and restore internal morale. Following the spring 2026 departures of former Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, the agency's interim leadership is moving quickly to reverse the damage caused by intense administrative downsizing fda-regulatory-pivot-advisory-committees-capricor-replimune
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"According to Acting Chief of Staff and Deputy Commissioner Lowell Zeta, the FDA has been authorized to hire 2,200 people. As of late June 2026, the agency has already secured 600 new hires—with several hundred currently in onboarding clearance..."
— fda-regulatory-pivot-advisory-committees-capricor-replimune
This rebuilding effort is critical to restoring the agency's basic operational capacity after losing more than 3,000 employees to deep budget cuts and early retirements fda-regulatory-pivot-advisory-committees-capricor-replimune. To prevent further operational paralysis, CBER’s Acting Director Karim Mikhail is personally conducting exit interviews to address staff dissatisfaction, while Center for Drug Evaluation and Research (CDER) Acting Director Michael Davis has successfully stabilized attrition back to historical norms fda-regulatory-pivot-advisory-committees-capricor-replimune.
What to watch: Watch whether the FDA can successfully onboard the remaining 1,600 authorized personnel to fully resolve review backlogs and stabilize its career workforce fda-regulatory-pivot-advisory-committees-capricor-replimune.
High-Stakes Advisory Panel Tests for Resubmitted Therapies
The regulatory path for previously stalled therapies is narrowing down to critical midsummer advisory panels, where clinical data must overcome both past rejections and complex partner disputes. The newly collaborative tone from federal regulators has breathed life back into applications like Replimune’s oncolytic immunotherapy RP1, which is being evaluated alongside Bristol Myers Squibb’s Opdivo fda-regulatory-pivot-advisory-committees-capricor-replimune.
"Following a 'collaborative dialogue' with the new acting leadership, Replimune submitted a third Biologics License Application (BLA) resubmission. On June 26, 2026, the FDA formally accepted the resubmission, designating it as a complete Class 1 response."
— fda-regulatory-pivot-advisory-committees-capricor-replimune
This rapid turnaround, coming after two prior rejections under the previous administration, underscores a deliberate pivot toward regulatory flexibility fda-regulatory-pivot-advisory-committees-capricor-replimune. However, the true test of this collaborative approach will occur in public, as expert panels evaluate both Replimune's application and Capricor Therapeutics' deramiocel—the latter of which is currently entangled in a major contract lawsuit with its commercial partner, NS Pharma, over unviable Medicare pricing structures fda-regulatory-pivot-advisory-committees-capricor-replimune.
What to watch: Watch how the Cellular, Tissue, and Gene Therapies Advisory Committee handles Capricor's deramiocel review on July 29, 2026, given the looming commercial dispute over its launch economics fda-regulatory-pivot-advisory-committees-capricor-replimune.
What surprised us
- The FDA's hiring engine is recovering faster than expected. Despite losing more than 3,000 employees during a brutal wave of job cuts, the agency managed to recruit and secure 600 new staff members by late June 2026 fda-regulatory-pivot-advisory-committees-capricor-replimune. This rapid onboarding suggests that the interim leadership's focus on morale and career-staff empowerment is successfully repairing the agency's reputation as an employer.
- A major clinical panel is proceeding despite partner litigation. Capricor is heading into a high-stakes July 29, 2026, advisory committee meeting for deramiocel while actively suing its own commercial partner, NS Pharma fda-regulatory-pivot-advisory-committees-capricor-replimune. It is highly unusual for a drug to face its most critical regulatory hurdle while its sponsors are locked in a legal battle over whether the therapeutic is even economically viable to distribute under government insurance plans.
Since last time
- Escalated — The FDA's operational state: The focus has shifted from the agency's policy initiatives (transparency/rejection letters) to its internal stability, specifically the massive hiring effort to recover from attrition following the departures of Makary and Prasad.
- Demoted — Replimune's review timeline: The specific detail regarding the 3-day turnaround between the advisory committee meeting and the PDUFA date is now a standard detail in the body text, rather than a "surprise."
- Disappeared — New Zealand H5N1 outbreak: No further mention of the avian influenza situation or the wildlife vaccination campaign.
- Disappeared — US Screwworm outbreak: No further mention of the containment efforts or trade impacts.
- Disappeared — FDA Rejection Letter Transparency: The initiative to publish rejection letters and the associated open thread (RIN 0910-AJ16) are entirely absent.
- Disappeared — Open threads: All previous open threads regarding FDA rules and NZ transmission have been dropped.
The FDA's Post-Attrition Rebuilding Campaign (Escalated)
The FDA is prioritizing internal stabilization to recover from the administrative downsizing that occurred during the spring 2026 departures of former Commissioner Marty Makary and CBER Director Vinay Prasad. The agency is currently executing a massive hiring campaign to address the loss of over 3,000 employees.
"According to Acting Chief of Staff and Deputy Commissioner Lowell Zeta, the FDA has been authorized to hire 2,200 people. As of late June 2026, the agency has already secured 600 new hires—with several hundred currently in onboarding clearance..."
— fda-regulatory-pivot-advisory-committees-capricor-replimune
Interim leadership is actively managing this recovery: CBER’s Acting Director Karim Mikhail is conducting exit interviews to address morale, while CDER Acting Director Michael Davis has reportedly stabilized attrition rates back to historical norms.
High-Stakes Advisory Panel Tests for Resubmitted Therapies (Escalated)
The agency's "regulatory pivot"—the move to fast-track previously rejected applications—continues, but the focus has shifted to the specific challenges of upcoming midsummer advisory panels. The FDA is maintaining a collaborative tone, as seen with Replimune’s RP1.
"Following a 'collaborative dialogue' with the new acting leadership, Replimune submitted a third Biologics License Application (BLA) resubmission. On June 26, 2026, the FDA formally accepted the resubmission, designating it as a complete Class 1 response."
— fda-regulatory-pivot-advisory-committees-capricor-replimune
While Replimune's application proceeds, the regulatory flexibility faces a new, complex test: Capricor Therapeutics' deramiocel review. This application is heading to an advisory committee on July 29, 2026, while simultaneously embroiled in a commercial lawsuit with partner NS Pharma over Medicare pricing viability.
What surprised us
- The FDA's hiring engine is recovering faster than expected. [NEW] Despite losing more than 3,000 employees during a brutal wave of job cuts, the agency managed to recruit and secure 600 new staff members by late June 2026 fda-regulatory-pivot-advisory-committees-capricor-replimune. This rapid onboarding suggests that the interim leadership's focus on morale and career-staff empowerment is successfully repairing the agency's reputation as an employer.
- A major clinical panel is proceeding despite partner litigation. [NEW] Capricor is heading into a high-stakes July 29, 2026, advisory committee meeting for deramiocel while actively suing its own commercial partner, NS Pharma fda-regulatory-pivot-advisory-committees-capricor-replimune. It is highly unusual for a drug to face its most critical regulatory hurdle while its sponsors are locked in a legal battle over whether the therapeutic is even economically viable to distribute under government insurance plans.
Open threads
- All previous open threads regarding FDA transparency and New Zealand biosecurity have been closed or removed from the current briefing scope.