Recall of contaminated pads not required
A potentially deadly bacterium was detected on alcohol prep pads produced by a New York medical manufacturer three months ago, but the product was not recalled until this week because federal regulators didn’t require it, the company said Wednesday. A day after the recall was launched Tuesday, word of it was slowly dribbling out to […]
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AMRI Receives FDA Notification on Proposed Corrective Actions
AMRI today announced the receipt of a letter from U.S. Food and Drug Administration (FDA) regarding its Burlington, Massachusetts aseptic finish-and-fill facility, acquired in June 2010. The letter pertained to AMRI’s written responses to a August 2010 warning letter and a June 2011 Form 483, and stated that corrective actions proposed by AMRI, once fully […]
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Mela Sciences surges on FDA nod
The FDA issues an “approvable letter” to Mela Sciences after its years-long battle for a U.S. green light for its hand-held skin cancer detection device, the MelaFind, sending the company’s shares up more than 90 percent in pre-market trading. Mela Sciences Shares of Mela Sciences (NSDQ:MELA) are on a tear today in pre-market trading on […]
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The Johnson & Johnson Recalls Just Keep on Coming
Just as Johnson & Johnson finally resumes shipments of one of its Tylenol over-the-counter meds, the healthcare giant is once again beset by manufacturing problems that have hurt sales and its venerable corporate image. This time, thousands of prefilled syringes containing its Eprex anemia drug have been recalled from 17 countries due to inconsistent potency. […]
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FDA backs Remicade for ulcerative colitis in children
The US Food and Drug Administration has granted another approval for Johnson & Johnson’s blockbuster Remicade, this time for the treatment of ulcerative colitis in paediatric patients who have had an inadequate response to conventional therapy. The healthcare giant noted that this marks marks the 16th approval of Remicade (infliximab) in the USA and the […]
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The ‘Witches Brew’ Of Drugs In The Water Supply
As a steady stream of studies and investigations reveal the extent to which pharmaceuticals are found in the US water supply, a new bill has been introduced in Congress that would create a non-profit organization to develop a nationwide program for disposing of medicines. And the non-profit would be financed by the pharmaceutical industry. “The […]
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AstraZeneca Rep Is Sued By Nexium Patients
In the pharmaceutical world, product-liability lawsuits are an everyday affair. Generally, a patient claims that a medicine caused them harm and a lawsuit accuses a drugmaker of failing to adequately warn of certain risks. Rarely, though, are individual sales reps also named as defendants. Now, though, two people have filed a lawsuit in a Texas […]
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The Johnson & Johnson Recalls Keep On Coming
Just as Johnson & Johnson finally resumes shipments of one of its Tylenol over-the-counter meds, the healthcare giant is once again beset by manufacturing problems that have hurt sales and its venerable corporate image. This time, thousands of prefilled syringes containing its Eprex anemia drug have been recalled from 17 countries due to inconsistent potency. […]
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FDA Biosimilar Guidance May Be Here In ‘Days’
The long-awaited arrival of the FDA guidance for biosimilars may be imminent, at least according to one agency official. Although the FDA plans to release the document by the end of the year, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Researcy, has indicated the guidance may be “as early as the […]
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Indian API Facility Slammed in Warning Letter
The FDA has fired off a strongly worded warning letter to Yag-Mag Labs Private Limited of India, hitting the API manufacturer with an import alert. According to the FDA, the company’s Hyderabad facility “was not adequately designed to facilitate cleaning and minimize the potential for contamination.” Inspectors saw “residues and corrosion on processing equipment,” leaky […]
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