WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.

Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece published Wednesday.

The announcement is the latest example of Makary and his team changing longstanding FDA standards and procedures with the stated goal of slashing bureaucracy and accelerating the availability of new medicines.

Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve “national interests.”

It contrasts with the FDA’s more restrictive approach to other products, including vaccines.

In their piece published Wednesday, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research “increasingly precise and scientific.”

“In this setting, overreliance on two trials no longer makes sense,” they write. “In 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

The FDA officials predicted the shift would lead to “a surge in drug development.”

Dr. Janet Woodcock, the FDA’s former drug director, said the change makes sense and reflects the FDA’s decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer.

“The scientific point is well taken that as we move toward greater understanding of biology and disease we don’t need to do two trials all the time,” said Woodcock, who led the FDA’s drug center for about 20 years before retiring in 2024.

The two-study standard for drugs dates to the early 1960s, when Congress passed a law requiring the FDA to review data from “adequate and well-controlled investigations,” before clearing new medications. For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients and significant follow-up time.

The reason for requiring the second study was to confirm that the first trial’s results weren’t a fluke and could be reproduced.

But beginning in the 1990s, the FDA increasingly began accepting single studies for the approval of treatments for rare or fatal diseases that companies often struggle to test in large numbers of patients.

Over the last five years, roughly 60% of first-of-a-kind drugs approved each year have been cleared based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or hard-to-treat conditions.

Woodcock said the new policy announced Wednesday will mainly impact drugs for common diseases that previously weren’t eligible for reduced testing standards.

“It’s not the cancers and the rare diseases that will be affected by this,” she noted. “The agency has been approving those on a single trial already.”

The latest approach from FDA leadership contrasts with the agency’s recent actions on vaccines, gene therapies and other treatments.

Last week, the FDA’s vaccine division, headed by Prasad, refused to accept Moderna’s application for a new mRNA flu shot, saying its clinical trial was insufficient. Then on Wednesday the agency reversed course, saying it would review the vaccine after Moderna agreed to conduct an additional study in older people.

Separately, Prasad has rejected a string of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend has weighed on the stocks of many biotech companies and clashed with Makary’s public statements promoting the speed and flexibility of the FDA’s reviews.

Woodcock said the drug industry will have to wait and see whether the FDA’s approach to promising experimental therapies changes.

“Implementation will be everything,” she said. “Since the agency’s approach is unclear, and the industry is already baffled, I don’t think this adds any illumination.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

President Donald Trump’s newly created Board of Peace is set to hold its first meeting Thursday, with administration officials and participating countries framing the gathering as a step toward implementing the next phase of the Gaza ceasefire and reconstruction effort rather than a moment likely to deliver an immediate breakthrough.

At least 20 countries are expected to attend the inaugural session in Washington, where Trump is slated to chair discussions on a multi-billion-dollar reconstruction framework, humanitarian coordination and the deployment of an international stabilization force.

Trump unveiled the initiative at the World Economic Forum in Davos last month. Initial members include the United Arab Emirates, Saudi Arabia, Egypt, Qatar, Bahrain, Pakistan, Turkey, Israel, Hungary, Morocco, Kosovo, Albania, Bulgaria, Argentina, Paraguay, Kazakhstan, Mongolia, Uzbekistan, Indonesia and Vietnam.

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On Sunday, Trump said members of the initiative had already pledged $5 billion toward rebuilding Gaza and would commit personnel to international stabilization and policing efforts. “The Board of Peace will prove to be the most consequential international body in history, and it is my honor to serve as its Chairman,” Trump wrote in a social media post announcing the commitments.

Italy’s foreign minister, Antonio Tajani, has announced a plan to train a future Gaza police force, while Indonesia has committed thousands of troops to a prospective international stabilization mission expected to deploy later this year.

The United Arab Emirates, a founding participant in the initiative, said it plans to continue its humanitarian engagement in Gaza.

“The UAE remains committed to scaling up its humanitarian efforts to support Palestinians in Gaza and to advancing a durable peace between Israelis and Palestinians,” the UAE Ministry of Foreign Affairs said in a statement, noting its role as a founding member of the Board of Peace and part of the Gaza Executive Board.

Even as Gulf and regional partners signal willingness to fund humanitarian needs, long-term reconstruction remains tied to security conditions on the ground.

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Disarmament remains the central test

Analysts say the meeting’s significance will hinge less on headline announcements and more on whether participants align on the unresolved core issue shaping Gaza’s future: Hamas’ disarmament.

Ghaith al-Omari, a senior fellow at the Washington Institute, argued the meeting’s credibility will depend on whether participants coalesce around a clear position on disarmament. “Unless there is going to be a joint statement coming out of it that clearly says Hamas has to disarm — to me the meeting would be a failure,” he said, because it would show “the U.S. cannot get everyone on the same page.”

Funding is also expected to dominate discussions, though diplomats and analysts caution that pledges may not translate quickly into large-scale reconstruction.

“We’re going to see pledges,” al-Omari told Fox News Digital, “with a footnote that a pledge does not always translate to deliverables,” urging attention to which countries commit funds and whether the money is earmarked for humanitarian aid, stabilization or long-term rebuilding.

John Hannah, a senior fellow at the Jewish Institute for National Security of America (JINSA), also cautioned that early financial pledges are unlikely to translate into immediate large-scale reconstruction. “I can’t imagine that much of that initial pledge or any of it is going to actual long-term or even medium-term reconstruction of Gaza. Just too many parties won’t support it, pending actual progress on the core question of disarmament and demilitarization of Hamas,” he said.

Hannah added that the financing challenge remains enormous. “It’s been a major outstanding question: How are you going to fund this tremendous bill that is going to come due over the course of the next several years?” he said. “I’ve been watching this now for 35 years, and if I had $100 for every time a major Arab country pledged support for the Palestinians but not delivered, I’d be a relatively wealthy man.”

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Netanyahu signs on despite Turkey, Qatar tensions

The initiative has also highlighted political tensions surrounding Israel’s participation, particularly given the involvement of Turkey and Qatar.

Israeli Prime Minister Benjamin Netanyahu signed on to the agreement last week during a meeting with Secretary of State Marco Rubio, placing Israel formally inside the framework despite earlier Israeli objections to Ankara and Doha playing a central role in Gaza’s future.

Hannah said Netanyahu’s decision reflects strategic calculations tied to Washington. “I think the prime minister doesn’t want to anger the president. He’s prioritizing his really good strategic relationship with Trump over this tactical difference over Turkey and Qatar,” he said. “The prime minister is just making a basic calculation of where Israel’s interests lie here and trying to balance these competing factors.”

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European allies raise legal concerns

Beyond Gaza, the initiative has sparked concern among European allies, many of whom have declined to join the board.

European officials told Fox News Digital the group’s charter raises legal and institutional questions and may conflict with the original U.N. framework that envisioned a Gaza-focused mechanism.

Speaking at the Munich Security Conference, European leaders argued the Board of Peace’s mandate appears to diverge from the U.N. Security Council resolution that initially supported a Gaza-specific body.

European Union foreign policy chief Kaja Kallas said the resolution envisioned a time-limited structure tied directly to Gaza and to the U.N., but that the board’s current charter no longer reflects those provisions. “The U.N. Security Council resolution provided for a Board of Peace for Gaza… it provided for it to be limited in time until 2027… and referred to Gaza, whereas the statute of the Board of Peace makes no reference to any of these things,” she said. “So I think there is a Security Council resolution but the Board of Peace does not reflect it.”

In response, U.S. Ambassador to the United Nations Mike Waltz criticized what he described as excessive concern over the initiative and argued the status quo in Gaza was unsustainable, and attacked what he said was “hand-wringing” about the Board of Peace — saying the cycle of war with Hamas in control had to be broken.

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Not a replacement for the United Nations

Despite European unease, analysts say the Board of Peace is unlikely to replace the U.N. system.

Al-Omari dismissed the idea that the initiative poses a serious institutional challenge, arguing that major powers remain deeply invested in the existing multilateral structure.

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Hannah agreed, saying the administration appears to view Thursday’s meeting primarily as incremental progress rather than any kind of major breakthrough. “The way the administration is looking at this is just another sign of continued progress and momentum, rather than any kind of major breakthrough,” he concluded.

The Spanish government’s controversial decision to approve a decree that will regularise 500,000 undocumented migrants and asylum seekers has sparked debate across Europe.

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Alongside more measured criticism and analysis, a wave of misleading claims has surfaced.

Some widely shared posts on X, amassing millions of views and thousands of shares, claim that these newly regularised migrants will be given the automatic right to vote.

Others say that they will be put on a fast track to citizenship, allowing them to vote and, in turn, creating a “loyal voting bloc” for Prime Minister Pedro Sánchez and his left-wing government.

When you look at Spain’s immigration, naturalisation and voting rules, there is little truth to these claims.

What does the decree entail and is it new?

The decree, expected to come into force in April, applies to at least 500,000 undocumented migrants and asylum seekers currently living in Spain.

Applicants for regularisation have to prove they have no criminal record and have lived in Spain for at least five months or sought asylum by the end of December 2025.

It’s not the first time Spain has regularised multiple migrants: the Spanish Commission for Refugee Aid (CEAR) said this is the seventh similar process since 1986.

The decree provides beneficiaries with a one-year residence permit and the right to work in Spain.

Sánchez’s government has said that the move will strengthen Spain’s labour market. Spain’s minister of inclusion, social security and migration, Elma Saiz, called it a “migratory model based on human rights, integration, co-existence and which is compatible with economic growth and social cohesion”.

The measure has equally sparked ire from the conservative People’s Party (PP) and the far-right Vox. The leader of the PP accused Sánchez of attempting to deflect attention away from the government’s response to multiple deadly train crashes over the past month.

Who can vote in Spain?

Spain’s voting rules are clearly defined.

According to the Spanish interior ministry, only Spanish citizens of legal age (currently 18 years old) are entitled to vote in national elections and elections in Spain’s autonomous communities. In European elections, EU citizens resident in Spain may also vote.

In local municipal elections, voting rights are more limited. Non-EU nationals may only vote if Spain has a reciprocal voting agreement with their country of citizenship. This applies currently to nationals of 13 countries, including Iceland, Norway and the UK, provided they also meet residency requirements (which can differ depending on the country).

Contrary to online claims, simply holding legal residence in Spain does not grant the right to vote in national elections.

Does regularisation lead to quick citizenship?

Another claim circulating on the viral posts suggests that regularised migrants can gain Spanish citizenship in as little as two years. But this is misleading.

Under Spanish law, only citizens of specific countries, namely Portugal, the Philippines, Andorra, Equatorial Guinea and most Latin American countries, as well as those of Sephardic origin, can apply for Spanish citizenship after two years of legal and continuous residence.

For the vast majority of people from other countries, though, it takes much longer: most immigrants to Spain need to live there legally for 10 years to be able to apply for citizenship, but this is shortened to five years for refugees and can be shortened even further to one year if the individual was born in Spain or has been married to a Spanish citizen.

Regardless of the timeframe, the residency period is just the start of the process. The decree itself grants one year of legal residency, meaning it would not be sufficient for the majority of people to gain citizenship in that time frame.

Applicants must still pass Spanish language and other tests, as well as wait for processing, which can take several years.

In conclusion, Spain’s new regularisation push grants migrants legal residence, not citizenship, and it does not confer voting rights in elections.

These rights are legally distinct in Spain and remain unchanged with this new decree.