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FDA will drop two-study requirement for new drug approvals, aiming to speed access

Published

2 weeks ago

February 18, 2026

FDA will drop two-study requirement for new drug approvals, aiming to speed access

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.

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World

Investors brace for a bigger backlash from Middle East war

Published

8 hours ago

March 1, 2026

Press Room

Investors brace for a bigger backlash from Middle East war

From being just a fringe risk, conflict in the Middle East has become a top worry for investors unsettled by the prospect of a power struggle in Iran and a protracted regional war, with ramifications for everything from global trade to inflation.

World

Tel Aviv analyst shelters from 30 missile sirens in 48 hours, says Iran ‘won’t recover’

Published

10 hours ago

March 1, 2026

Press Room

Tel Aviv analyst shelters from 30 missile sirens in 48 hours, says Iran ‘won’t recover’

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The past 48 hours in Tel Aviv have been unlike anything seen before, a leading security analyst has said, as sirens blared amid missile threats following Operation Epic Fury and U.S.-Israeli strikes in Iran.

“We are facing a biblical event — nothing less,” Kobi Michael, a senior researcher at the Institute for National Security Studies and the Misgav Institute, told Fox News Digital, speaking from his shelter in the city.

Like many Israelis, Michael said he had spent hours in reinforced rooms during the ongoing barrage, adding that he was “very experienced in this.”

“But this all requires time and determination, and I do hope that Trump will also have them both,” he said, speaking shortly after the president released a video message stating that the military operation would continue “until all of our objectives are achieved.”

Explosions from projectile interceptions by Israel’s Iron Dome missile defence system over Tel Aviv. (JACK GUEZ / AFP via Getty Images)

“Trump is the only one who can make the change — and that change will impact the entire region and the international order for years to come,” Michael added.

As of Sunday, Tel Aviv remained under a state of emergency following Iranian missile attacks that caused casualties and widespread damage.

According to The Associated Press, Iranian missile and drone strikes have killed approximately 11 Israeli civilians and wounded dozens more in retaliation for the U.S.-Israel strikes on Iran.

Shrapnel from missile impacts damaged at least 40 buildings in Tel Aviv, and authorities reported at least one death in the area from falling debris.

The Philippine Embassy in Israel confirmed the death of a Filipino national after a missile strike hit Tel Aviv on Saturday.

TOMAHAWKS, B-2 STEALTH BOMBERS AND ATTACK DRONES POUND OVER 1,000 IRANIAN TARGETS IN 24-HOUR BLITZ

People take shelter as Iran launched missiles and drones towards Israel following the US-Israeli attacks. ( Mostafa Alkharouf/Anadolu via Getty Images)

“We enter our shelter once the siren is heard and stay there until the Home Front Command announces that we can leave,” Michael said.

“Usually, it is about 20 to 30 minutes — unless there are further sirens during our stay. Since yesterday morning, it has happened around 30 times.”

Israel’s President Isaac Herzog also visited an impact site in Tel Aviv Sunday, delivering a message of resilience.

“The people of Israel and the people of Iran can live in peace. The region can live in peace. But what undermines peace time and again is terror instigated by this Iranian regime,” Herzog said.

EXILED IRANIAN CROWN PRINCE SAYS US STRIKES MARK ‘BEGINNING OF THE VERY END’ FOR REGIME

Israeli emergency service officer walks past building debris at the scene of a Iranian missile attack. (Ahmad GHARABLI / AFP via Getty Images)

Following the reported killing of Iran’s Supreme Leader Ayatollah Ali Khamenei and roughly 40 senior Iranian officials, Iran formed a provisional leadership council.

Iran named Ayatollah Alireza Arafi, President Masoud Pezeshkian and Judiciary Chief Gholam-Hossein Mohseni-Eje’i to lead roles.

“The Supreme Leader did not complete the necessary groundwork regarding his own succession,” Michael added.

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“Pezeshkian will face very troubling challenges due to their heavy losses, severe disruptions to control and command systems, and the massive bombing and attacks across Iran, including Tehran,” he said.

“Even if this regime doesn’t collapse, it will never be able to reconstitute itself, recover or return to its previous position,” Michael added.

Emma Bussey is a breaking news writer for Fox News Digital. Before joining Fox, she worked at The Telegraph with the U.S. overnight team, across desks including foreign, politics, news, sport and culture.

World

Israel FM says Europe too divided, slams Spanish PM

Published

11 hours ago

March 1, 2026

Press Room

Israel FM says Europe too divided, slams Spanish PM

Israeli minister Gideon Sa’ar said Europe “does not have unified position” on what role it should play in Iran as European ministers sought to establish a joint approach Sunday.

As Israel and the United States conducted a joint military strike on Iran, leading to the killing of Supreme Leader Ayatollah Ali Khamenei, Europe was kept on the sidelines.

EU member states did not participate in the operation and, in some cases, they were not informed prior as it is customary among strategic allies.

Asked whether Israel sought to keep Europe on the margins, Sa’ar said internal divisions within EU member states had kept them out of critical exchanges of operational details, unlike the United States, which the minister described as his country’s greatest ally.

“In Europe, you have all kinds of approaches,” he told Euronews. “You have countries like the Czech Republic which is strongly supporting this operation and then you have Spain, which is standing with all the tyrants of the world.”

On Saturday, Spanish prime minister Pedro Sánchez was among the most critical voices in Europe, suggesting the US-Israeli strikes on Iran risk plunging the region into total war.

“We reject the unilateral military action of the United States and Israel, which represents an escalation and contributes to a more uncertain and hostile international order,” Sánchez said Saturday. The Spanish PM reiterated that message on Sunday.

“We urge for de-escalation and call to respect international law in all conflicts,” Sánchez added. “You can be against a heinous regime, like the Iranian regime, while also rejecting a military intervention that is unjustified, dangerous and outside of international law.”

Sa’aar said Israel considers the operation “fully justified” citing the right to self-defense from a regime that “has called for the destruction of Israel” and lashed at the Spanish prime minister for sending an “anti-Israeli, anti-American message.”

“Read the statement, they are standing with Iran!” he added.

When asked if any of his European counterparts had manifested an interest in joining the military operation or provide support on the ground, Sa’ar said he held multiple exchanges with European ministers over the weekend and suggested that “if others want to join, they will know have to convey the message.”

On Sunday, Commission President Ursula von der Leyen appeared to back regime change in Iran in line with Israel and the US, saying that the “risk of further escalation is real. This is why a credible transition in Iran is urgently needed” in comments on Sunday.

Sa’ar told Euronews said the strategic strikes and the elimination of Khamenei alongside top regime commanders could “create the conditions to weaken the regime enough to allow the Iranians to take their future into their own hands”.

“The future leadership of Iran should be determined by the Iranian people through free elections. Our only requirement is that whoever comes to power in Iran must not pursue the destruction of Israel,” he said.

Watch the full interview on Euronews from 8pm CET