FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.
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.'"
The regulator and patients will chat for two days in October.
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.
The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.
The experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis.
Three House democrats are asking the FDA to get the chemical out of US drugs ASAP.
The FDA issued a Warning Letter over unapproved drug claims published in Spanish.
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.
The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.
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.
It's the second for this cancer drug in two weeks.
The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.
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.
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.
Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.
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.
The regulator wants men to be part of breast cancer clinical trials.
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.
Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.
The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.
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.
The regulator's latest study will use eye-tracking tools.
The regulator is allocating almost $38 million to improve data-guided decision-making.
The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.
A three-year, $1 million project seeks an equation for generics and biosimilars.
Novartis says the FDA wants more serelaxin efficacy data.
The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.
The regulator defends its approval decision in a web post.