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FDA

Latest Headlines

Latest Headlines

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.

Ulthera device clears FDA for décolleté on heels of Merz acquisition plans

Merz already committed to buying Ulthera for up to $600 million in cash and milestones. Now it will get another FDA-cleared indication as part of the bargain. The company's system has cleared the FDA to improve the lines and wrinkles of the décolleté.

FDA IT modernization push set to continue under 2014-2018 strategic plan

When the FDA laid out its strategic priorities for 2011 to 2015, the agency listed the modernization of its IT infrastructure as a primary objective. Since then, the FDA has seen another chief information officer pass through its revolving doors and faced criticism from the Government Accountability Office, but is still plugging away with the IT modernization agenda in its next strategic plan.

FDA wants an EMR database to boost oversight of drug safety

The potential to mine electronic medical records for insights into disease prevalence, drug adherence, patient safety and a host of other areas has attracted a who's who of Big Pharma, with the likes of GlaxoSmithKline, Johnson & Johnson and Pfizer all running programs. And now the FDA is pushing ahead with its plans by seeking access to a patient-level database.