FDA

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.

India's Marck gets FDA Warning Letter

Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"

FDA tackles women's sexual health

The regulator and patients will chat for two days in October.

Colorectal cancer test is FDA moment of sorts

Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.

FDA clocks record number of recalls

The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.

FDA grants Fast Track to Baxter JAK inhibitor

The experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis.

Lawmakers want FDA to boot phthalates

Three House democrats are asking the FDA to get the chemical out of US drugs ASAP.

FYI: FDA habla español

The FDA issued a Warning Letter over unapproved drug claims published in Spanish.

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

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FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

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The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

BI drug gets priority review

Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.

Researchers give FDA social media advice

Researchers give FDA social media advice

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Researchers from Boston Children's Hospital, Harvard Medical School and Brigham and Women's Hospital are offering a bit of internet advice for the Food and Drug Administration: do more.

FDA wants male breast cancer patients

The regulator wants men to be part of breast cancer clinical trials.

Vertex to submit CF drug combo to FDA this year

Vertex to submit CF drug combo to FDA this year

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Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.

PhRMA uneasy about "right-to-try" laws

Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.

Lilly, BI resubmit diabetes medication

The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.

HealthKit won't tangle with the FDA

Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.

Campaigners want FDA to focus on women's sexual health

Campaigners want FDA to focus on women's sexual health

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A coalition of organizations, including pharmaceutical company Sprout, kicked off a campaign urging the FDA to pay as much attention to women's sexual dysfunction needs as it does to men's.

FDA examines DTC close up

FDA examines DTC close up

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The regulator's latest study will use eye-tracking tools.

FDA invests in clinical trial data

The regulator is allocating almost $38 million to improve data-guided decision-making.

Sun's FDA Warning Letter

Sun's FDA Warning Letter

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The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.

FDA seeks math of similarity

A three-year, $1 million project seeks an equation for generics and biosimilars.

FDA says no to Novartis heart drug

FDA says no to Novartis heart drug

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Novartis says the FDA wants more serelaxin efficacy data.

BMS, AbbVie land Breakthrough label

The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.

FDA standing by its Zohydro approval

FDA standing by its Zohydro approval

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The regulator defends its approval decision in a web post.

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