FDA Archives

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Politics By Nicholas Florko

Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one

D.C. Diagnosis By Lev Facher

The Senate health committee finally marks up its user fee bill

First Opinion By Dana Singiser

‘Pink tape’ at the FDA is delaying access to contraception — again

Politics By Lev Facher

Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals

Politics By Nicholas Florko

Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions

D.C. Diagnosis By Nicholas Florko

The FDA’s Rob Califf on importing drugs from Canada, on Aduhelm, and on opioids

Politics By Nicholas Florko

Medicare’s Brooks-LaSure expects restrictions on accelerated approval drugs, like those for Aduhelm, to be ‘very rare’

Pharma By Ed Silverman

The revolving door swings again as Lupin hires an FDA official who oversaw problems at a key plant

D.C. Diagnosis By Nicholas Florko

The FDA’s ban on menthol in cigarettes clears a major regulatory hurdle

Politics By Nicholas Florko

Right to try 2.0: Advocates want to reduce oversight of ‘n of 1’ therapies

Politics By Nicholas Florko

CDC, FDA, and NIH staffers aren’t reporting political interference, new watchdog report shows

D.C. Diagnosis By Nicholas Florko

The next battle in the never-ending war over Aduhelm

D.C. Diagnosis By Nicholas Florko

Faced with high drug prices, seniors are abandoning cancer drugs at the pharmacy

Politics By Nicholas Florko

Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency

Politics By Nicholas Florko

An ALS therapy sets up a crucial test of the FDA’s independence

First Opinion By Anthony Yanni

Welcome back, Dr. Califf: Patients will see you now

Politics By Nicholas Florko

Lawmakers face off about the future of the FDA’s accelerated approval pathway

Politics By Nicholas Florko

Congress moves toward giving FDA authority over synthetic nicotine products like Puff Bar

D.C. Diagnosis By Nicholas Florko

Covid budget crunch looms over government funding fight

Politics By Nicholas Florko

Key Democrat moves to crack down on FDA accelerated approvals

D.C. Diagnosis By Nicholas Florko

The FDA’s promised menthol ban is about to face a critical test

Politics By Nicholas Florko

FDA asks Congress for more power to regulate certain diagnostic tests, including prenatal screenings

D.C. Diagnosis By Nicholas Florko

Is the Senate gearing up to actually pass drug pricing legislation?

Politics By Nicholas Florko

6 approval decisions that will make or break Califf’s first year at the FDA

Politics By Nicholas Florko

Most Read

A no good, very bad week for the FDA

The FDA says it’s in the dark about thousands of dietary supplement ingredients

As Congress takes up FDA oversight of dietary supplements, a lobbying showdown looms

Senate FDA legislation will include dietary supplement, cosmetic reforms

Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?

The FDA needs to take another look at laser-based ‘vaginal rejuvenation’

It’s too early to tell whether CBD helps against Covid-19 — but researchers worry that won’t stop CBD makers

Containing Covid-19 requires rapid tests that are highly sensitive to infections. Why is the FDA asking for something different?

All Coverage

Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one

The Senate health committee finally marks up its user fee bill

‘Pink tape’ at the FDA is delaying access to contraception — again

Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals

Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions

The FDA’s Rob Califf on importing drugs from Canada, on Aduhelm, and on opioids

Medicare’s Brooks-LaSure expects restrictions on accelerated approval drugs, like those for Aduhelm, to be ‘very rare’

The revolving door swings again as Lupin hires an FDA official who oversaw problems at a key plant

The FDA’s ban on menthol in cigarettes clears a major regulatory hurdle

Right to try 2.0: Advocates want to reduce oversight of ‘n of 1’ therapies

CDC, FDA, and NIH staffers aren’t reporting political interference, new watchdog report shows

The next battle in the never-ending war over Aduhelm

Faced with high drug prices, seniors are abandoning cancer drugs at the pharmacy

Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency

An ALS therapy sets up a crucial test of the FDA’s independence

Welcome back, Dr. Califf: Patients will see you now

Lawmakers face off about the future of the FDA’s accelerated approval pathway

Congress moves toward giving FDA authority over synthetic nicotine products like Puff Bar

Covid budget crunch looms over government funding fight

Key Democrat moves to crack down on FDA accelerated approvals

The FDA’s promised menthol ban is about to face a critical test

FDA asks Congress for more power to regulate certain diagnostic tests, including prenatal screenings

Is the Senate gearing up to actually pass drug pricing legislation?

6 approval decisions that will make or break Califf’s first year at the FDA

Senate narrowly confirms Robert Califf to lead the FDA

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