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FDA

Latest Headlines

Latest Headlines

FDA again warns that Texas compounder's products may not be sterile

The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.

FDA in search of a new head for its Indian operations

When India-born Altaf Lal was named to run the FDA office in India last year, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency. But someone else will have to take on that challenge because Lal has left after just about 9 months on the job.

Animal health companies not exempt from FDA marketing regs, either

The FDA issued Paris-based AB Science a warning letter regarding its Kinavet-CA1 canine drug, intended for mast cell tumors in dogs, for allegedly boasting its off-label uses without approval.

FDA adds recalls API as openFDA initiative gathers pace

The FDA is continuing to push ahead with its openFDA initiative, with this week's rollout of an application programming interface (API) for recall data coming a month after its adverse event system went live. And the regulator plans to maintain the pace throughout the rest of the summer.

Top officials at FDA's India office bolt after less than a year

FDA Commissioner Margaret Hamburg has urged India's drugmakers and regulators to get on board with international quality standards, while promising close cooperation from its expanded office there. But efforts are being hampered by the exit of top officials.

GSK recalls acetaminophen products that were not child-proofed

GlaxoSmithKline is voluntarily recalling four lots of its Panadol Advance product in 100-count bottles in Puerto Rico because the bottles do not have child-resistant packaging to protect against overdoses.

FDA garbles social media education, but social media discipline is clear enough

The FDA may be having problems handing down its social media commandments. But it's playing enforcer just the same.

In social media, what's easier to grasp--an FDA webinar or an FDA warning?

The FDA may be having problems handing down its social media commandments. But it's playing enforcer just the same.

FDA cites Italian API maker for deleting all analytics

FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.

India faces higher QC costs as Shasun shows value of compliance

Rising recognition of FDA scrutiny and the cost of quality failings have prompted Indian drugmakers to double spending on compliance over the past 5 years, credit rating agency Crisil reports. And Indian investors are increasingly conscious of the value of such investments, with Shasun Pharma seeing its stock jump 16% this week after it got through an FDA inspection with just a Form 483.