Robert Califf receives support from 54 organizations to be commissioner of the FDA

FDA launches consolidated adverse event reporting system

FDA has created a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events.

March 20, 2026

Vol.52 No.11

By Claire Marie Porter

Cancer Policy

House bill proposes to exempt health care workers from H-1B visa $100,000 fee

The H–1Bs for Physicians and the Healthcare Workforce Act—introduced by Rep. Sanford D. Bishop, Jr. (D-GA) and Rep. Mike Lawler (R-NY)—would exempt physicians and health care workers from a recently imposed $100,000 fee now required to obtain an H-1B visa, which allows foreign nationals in “specialty occupations” to live and work in the U.S. The fee was previously $5,000 to $10,000.

CBER Director Vinay Prasad dared to “say no to drugs”

FDA’s Center for Biologics Evaluation and Research Director Vinay Prasad is set to leave the agency for a second time amid controversy.

March 18, 2026

Regulatory News

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Amid deepening controversy, Vinay Prasad, FDA’s top clinician and scientist, and director of its Center for Biologics Evaluation and Research, will be leaving the agency.

March 13, 2026

Vol.52 No.10

By Claire Marie Porter

Regulatory News

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

On Jan. 9, Pierre Fabre Pharmaceuticals received a “complete response letter” from FDA: its application for the T-cell therapy tabelecleucel (Ebvallo) was getting a hard No.

FDA approves leucovorin for cerebral folate deficiency

FDA has approved leucovorin calcium tablets (Wellcovorin), expanding its use for the treatment of cerebral folate deficiency in adult and pediatric patients.

March 13, 2026

Vol.52 No.10

By Claire Marie Porter

Robert Califf receives support from 54 organizations to be commissioner of the FDA

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FDA launches consolidated adverse event reporting system

House bill proposes to exempt health care workers from H-1B visa $100,000 fee

CBER Director Vinay Prasad dared to “say no to drugs”

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA approves leucovorin for cerebral folate deficiency

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Robert Califf receives support from ​​54 organizations to be commissioner of the FDA

YOU MAY BE INTERESTED IN

FDA launches consolidated adverse event reporting system

House bill proposes to exempt health care workers from H-1B visa $100,000 fee

CBER Director Vinay Prasad dared to “say no to drugs”

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

FDA approves leucovorin for cerebral folate deficiency

Never miss an issue!

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Robert Califf receives support from 54 organizations to be commissioner of the FDA

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”