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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Finally, J&J Resumes Some Tylenol Shipments
For more than a year, we have spent considerable time tracking the ongoing and rather impressive number of recalls by Johnson & Johnson which, you may recall, blundered into a series of manufacturing gaffes and questionable coping strategies that generated an FDA probe; congressional hearings; lost sales; a closed plant; managerial changes; eroded consumer confidence; […]
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Yag Mag Labs Private Limited 9/12/11
Mr. M. Soma Raju Yag-Mag Labs Private Limited Plot 7, Flat 301 Besides Andhra Bank, Sundar Nagar, Near ESI Hyderabad 500 038, Andhra Pradesh, India Dear Mr. M. Soma Raju, During our June 27 to July 2, 2011 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Yag-Mag Labs Private Limited located at Survey No. […]
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Strides Gets Continued US FDA Approval Status For Its Oral Dosage Facility
Strides Arcolab said US FDA recently inspected its Oral Dosage Forms manufacturing facility in KRS Gardens in Bengaluru, as part of GMP compliance audit, and the facility continued to be approved with Zero Inspectional Observation’ reported in FDA 483. The last US FDA inspection and approval for this facility was in the year 2008. The […]
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