US FDA flags quality issues at three Philips' facilities

The U.S. Food and Drug Administration has flagged three of Philips' medical device facilities after inspections found they had failed to meet required manufacturing standards, according to an update on the agency's website on Tuesday.

FDA grants breakthrough status to Augurex’s axSpA diagnosis test

The US Food and Drug Administration (FDA) has granted breakthrough device designation to Augurex Life Sciences’ SPINEstat 14-3-3eta Autoantibody Multiplex Immunoassay Test for axial spondyloarthritis (axSpA) diagnosis.
ConsumerAffairs

FDA recalls generic Lipitor tablets used by millions of seniors

Nearly 142,000 bottles of atorvastatin calcium tablets recalled nationwide • Faulty dissolution may limit drug absorption and cholesterol control • Sen
BioSpace

FDA Struggles to Keep Lights On Amid Shutdown as Biopharmas Begin To See Delays

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.

Exclusive: BAT pauses unlicensed US vape launch as FDA action accelerates

British American Tobacco said it has paused a pilot plan to launch an unlicensed disposable vape in the U.S., as the Food and Drug Administration moves to crack down on unregulated products and speed up licences.

Philips Had Received Warning Letter From FDA on Medical Device Facilities

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a Philips Medical Systems facility in Eindhoven, the Netherlands.
UVA Today

Q&A: What new drug is the FDA reviewing to treat Parkinson’s disease?

If approved, it would be the first major new drug treatment for Parkinson’s in half a century. Richard Mailman, a University of Virginia professor of pharmacology and neuroscience, has spent decades trying to bring this class of drug to patients.
Spot.ph

Tell Your Titas: Batch of Hong Thai Inhalers Found Unsafe After Failing FDA Test

The affected products contains bacterial levels higher than what is allowed.

FDA Announces Recall of 4 Popular Cheeses for Potential E. Coli Contamination

For a full list of the manufacturer codes and label images, visit the FDA website.
Fierce Pharma

Birds, lizards and cats, oh my: FDA blasts generic drug maker Hetero in scathing Form 483

The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India uncovered flying bir | The FDA slammed generics maker Hetero with a Form 483 after an inspection of one of its warehouses in India uncovered flying birds,
Healio

FDA updates Winrevair indication in PAH, highlighting impact in high-risk patients

The FDA approved a label update for Winrevair to include that it lowers the risk for clinical worsening events in adults with advanced pulmonary arterial hypertension, according to a press release from Merck.
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