FDA Urges Indian Pharma to Make Quality #1 Priority
Top management of drugmaking companies must make quality control their top priority, said a senior USFood and Drug Administration (FDA) official at Hyderabad kicking off a series of FDA- Drug Controller General of India workshops to be held this year for Indian pharma companies to help them comply better to the US prescribed standards. “Companies […]
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FDA Targets E-Cigs
The most recent Food and Drug Administration proposed regulations affecting e-cigarettes raise serious policy and civil liberties questions about the role of government when it attempts to address a societal problem such as smoking. The F.D.A. should not overstep its authority and encroach on the principles and values of freedom and liberty that are the […]
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Massachusetts Can’t Outlaw an FDA-Approved Painkiller
A federal judge on Tuesday blocked an effort by Massachusetts Gov. Deval L. Patrick to ban sales of a controversial new painkiller in the state, saying the governor’s move was preempted by federal law and could harm people who need the drug for pain relief. In a five-page order, U.S. District Judge Rya W. Zobel […]
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Dangerous Documents – Don’t Be Haunted By Your Words
Don’t Be Haunted By Your Words How to Avoid Document Mistakes That Destroy Your Credibility and Lead to Legal Trouble By Nancy Singer and Joseph Pickett Nancy Singer is the creator and presenter of the 5-hour in-person seminar and 90 min summary webinar Dangerous Documents: Avoiding Land Mines in Your Emails and Documents. She began […]
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FDA Blasts Sun Pharma for Torn Records and Dirty Toilets
Torn documents, partially destroyed raw data showing undesirable results and unclean toilets were among the reasons cited by FDA for the ban it imposed last month on a Gujarat-based facility of Sun Pharma, the largest Indian drugmaker. “Drug products failing to meet established specifications and quality control criteria are not rejected,” said a form 483 issued […]
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GSK Announces Recall After Nasty FDA Warning Letter
GlaxoSmithKline has said it will recall some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been tainted. But the U.K.-based drugmaker didn’t decide to take the step until it was publicly chastised by the FDA about the problem in a warning letter. FDA posted the warning letter to its website Tuesday citing […]
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Wockhardt Gibberish in Reply to FDA?
I love the nonsense that companies put in their replies to accusations of willful negligence. Consider this from Wockhardt after a US FDA inspection found piss, mold and samples tested “into compliance” [emphasis mine] at its Chikalthana manufacturing plant in Aurangabad, India. “We are also leveraging technology and deploying enterprise-wide software that will streamline the entire quality and compliance […]
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FDA Gives OK to Heroin/Painkiller Overdose Antidote
Last week, FDA approved a device on Thursday that reverses the effects of overdoses from opioids, including heroin and prescription painkillers. Called Evzio, the injection-style device administers the drug naloxone. Naloxone has long been used in ambulances and emergency rooms to treat opioid overdoses. Now Evzio allows caregivers, family members and non-medical personnel to keep […]
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OxyContain Manufacturers to Make Abuse-Resistant Pain Killer
Soon after FDA announced last week that Zohydro – a painkiller that is supposed to be 10x more potent than Vicodin – is going to be made available in CA this month, the manufacturers of OxyContin stated that they are going to submit their own abuse-resistant painkiller to FDA for approval. The new drug, which […]
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FDA Advisory Panel Says New HPV Test Better for Cervical Cancer Screening
An FDA advisory panel voted unanimously this week that a new HPV test could be used before or instead of the Pap smear as a first step in cervical cancer screening. In three separate 13-0 votes, the agency’s Medical Devices Advisory Committee Microbiology Panel concluded that the cobas HPV (human papillomavirus) test, made by Roche […]
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