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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Study Finds Quality Risk Gap Between US, PR Plants
Location apparently does matter to drug quality risk after all. Even though pharma companies may be able to produce their meds more cheaply offshore than on, “substantial evidence” shows the quality risks are higher, according to recent research. “It’s a powerful result that is surprising to many people,” says John Gray of Ohio State University’s […]
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U.S. district judge rejects FDA’s attempted regulatory authority over compounding pharmacies in United States v. Franck’s Lab, Inc.
On September 12, 2011, the U.S. District Court for the Middle District of Florida in United States v. Franck’s Lab, Inc. denied a request by the U.S. Food and Drug Administration (“FDA”) for an injunction and summary judgment against a compounding pharmacy, Franck’s, and firmly rejected the FDA’s contention that it had per se authority […]
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FDA phases out inhaler due to environmental impact
Federal health officials are alerting asthma patients that a type of inhaler sold over the counter will be phased out at year’s end because it uses carbon gas that depletes the Earth’s atmosphere. The Food and Drug Administration says patients who use the epinephrine inhalers will need to switch to other types of inhalers which […]
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A Controversial Bayer Drug Returns To Canada
Four years after Bayer agreed to suspend sales of its Trasylol drug, which is used to control bleeding during heart surgery, Health Canada is allowing the drugmaker to resume sales after conducting a safety review that the agency says shows the benefits outweigh the risks. NEW WEBINAR – What You’ve Got to Know About the […]
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Drugmakers Fined By South Korea Over Kickbacks
Yet another country is starting to crackdown on kickbacks. The Korea Fair Trade Commission has just announced that six drugmakers were fined for organizing free seminars and conferences for doctors, clinics and hospitals, and then offering golf outings; carpets; wine; dinners; speaking and consulting fees; spa treatments; movie showings and old-fashioned cash for purportedly conducting […]
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Kansas Doctor, Researcher Accused Of Falsifying Data Expected To Change Plea
A Kansas doctor and a researcher accused of falsifying data in a clinical drug trial appear ready to change their pleas next month. NEW WEBINAR – What You’ve Got to Know About the Incoming Bombshell – FDA’s 2011 Process Validation Guidance Federal court notations show change-of-plea hearings are scheduled Oct. 19 for Wayne Spencer, a […]
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A Controversial Bayer Drug Returns To Canada
Four years after Bayer agreed to suspend sales of its Trasylol drug, which is used to control bleeding during heart surgery, Health Canada is allowing the drugmaker to resume sales after conducting a safety review that the agency says shows the benefits outweigh the risks. NEW WEBINAR – What You’ve Got to Know About the […]
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