Astrazeneca Axes Another 2300 Jobs
Upcoming Events! March 28 – Why You May Want to Move Your Pharma Company to Kansas – 483 and Warning Letter Trends April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April […]
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Cephalon Accused of Fraud
Upcoming Events! March 28 – Why You May Want to Move Your Pharma Company to Kansas – 483 and Warning Letter Trends April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April […]
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Top five tips for successfully addressing warning letters
Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will ultimately return to the agency’s good graces and through the experience develop processes that result in better business […]
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FDA warns sexual enhancement supplements contain hidden drugs
FDA is warning consumers Thursday that several supplements advertised as sexual enhancements contain hidden drugs. A supplement called “Stiff Days” contains sildenafil, the active ingredient in prescription drug Viagra, which is used to treat erectile dysfunction; “Rock-It Man” contains a similar compound called hydroxythiohomosildenafil; and “Libido Sexual Enhancer” contains both of those ingredients as well as tadalafil, […]
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FDA Inspection Close Up – Using Strong Process Mapping and Gap Analysis
March 24, 2013 Essential FDA Compliance Tips for Sr. Management When FDA arrives at your manufacturing plant, you might feel a twinge of panic. Or maybe you regret that you did not have time to solve some of the problems the FDAers may reveal. But, know that FDA inspection panic and regret is not something […]
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Apotex Slammed With Another Serious Warning Letter
Tomorrow – The Quality Manager Gets Fired and the $125,000 Compliance SNAFU In the latest row between the FDA and Apotex over its manufacturing practices, the agency has issued another warning letter that takes the generic drugmaker to task for a host of serious violations at two separate plants in Canada. The missive also notes […]
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Aurobindo Employees Rip Raise
Tomorrow – The Quality Manager Gets Fired and the $125,000 Compliance SNAFU At least one generic drugmaker has found yet another way to mimic brand-name drugmakers – an alleged failure to pay promised wages and a resulting protest by employees. Aurobindo had purportedly committed to raising salaries for its workers by March 15, but only […]
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FDA Names Acting Head of Generic Drugs Office
Tomorrow – The Quality Manager Gets Fired and the $125,000 Compliance SNAFU FDA has named Dr Kathleen Uhl acting director of itsgeneric drugs division as it implements the biggest revamp of the department in more than a decade. Uhl replaces Dr Gregory Geba, who resigned abruptly last week after just eight months on the job, saying the reorganization will change […]
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Doctors urge FDA to limit caffeine content in energy drinks
Tomorrow – The Quality Manager Gets Fired and the $125,000 Compliance SNAFU A group of health experts urged the Food and Drug Administration Tuesday to take action and protect teens from the possible risks of drinking large amounts of caffeine from energy drinks, The New York Times reported. “There is evidence in the published scientific […]
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Dangerous Documents: How to Avoid Land Mines in Your FDA Documents and Emails | In Person Workshop | Singer
Dangerous Documents: Avoiding Land Mines in Your Emails and Documents is a absolutely unique all day, in person event with former DOJ prosecutor Nancy Singer – where you will discover the potential consequences of writing emails and other documents that are inappropriate. After this in person, all day workshop event, your employees will be motivated […]
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