FDA scathing of Australian vaccine maker
The world’s most powerful drugs industry regulator has accused the Australian company that makes the flu vaccine of not doing enough to find out why it caused fever and convulsions in children. The US Food and Drug Administration (FDA) has issued a stern warning to CSL and threatened to withdraw its license if the company […]
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483 Bundle – 50 from 2010
2010 Pack | 50 pre-selected 483s from 2010 Price: $1,299 Includes 483s from companies such as: Abbott, ActiTech, Baxter, Amgen, H&P, Gilead, J&J Merck, McNeil Healthcare, Hospira, Sanofi Aventis, Pfizer, Par Pharmaceuticals, Oakwood Laboratories, Schwarz Pharma Manufacturing, Nonin Medical, Libby Laboratories, and Hitachi Chemical. Click here to visit FDAzilla and purchase.
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FDA 483s Listing | 2010 and Q1 2011
If avoiding FDA 483s are a part of your job, this list is a must-have. Great for trending, geographic, seasonal, and keyword analyses as well as getting a clear picture of the FDA’s most recent 483s. For each 483, you will get information such as FEI number, inspection date, company name, address, and country. Price: […]
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Individual 483s for Sale
Get pharma/biotech 483s instantly and anonymously for $39 per report. Browse through our data base of 240+ 483s by company name, inspection date, number of observations, and manufacturing facility type. Price: $39 each Click here to visit FDAzilla.
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Top Seven Strategies for Avoiding 483s Report | Pharma/Biotech Sector
The FDA has warned numerous times that they expect you to monitor the happenings of your peers — rather than wait for the FDA to show up to identify the same problems. You can do just that with a new resource from FDAzilla. Price: $749 Click here to visit FDAzilla and purchase. Enter ‘no483s’ at […]
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FDA And A New ‘Global Strategy’ For Imports
Beset by an inability to thoroughly monitor pharmaceutical ingredients and production around the world, the FDA has declared a new ‘global strategy’ to cope with the fast-paced industry changes that are straining its resources. And in issuing a 37-page report on the topic, the agency says the step reflects a lack of “resources to adequately […]
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Amgen Must Let Feds Interview Its Employees
For the past five years, the US Attorney in Brooklyn, New York, has been investigating Amgen for allegedly violating the False Claims Act. At issue are a host of allegations, most notably that Amgen violated HIPAA and offered kickbacks to doctors in order to boost sales of its various meds and steal market share from […]
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FDA Says It Needs New Approach on Imports
Border and port inspections alone aren’t sufficient to make sure the imported food and drugs consumed by U.S. residents are safe. That’s the word from the FDA, which today laid out a plan to monitor the rising tide of goods from abroad. It includes planned partnerships with counterpart regulators in other countries and better data-sharing […]
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Bayer Off-Label Promotion Of Yasmin Birth Control Pill For Acne Caused Teenager’s Death: Lawsuit
The thousands of lawsuits filed against Bayer over alleged injuries and deaths relating to the Yaz and Yasmin contraceptives typically dwell on higher risks beyond those of traditional birth control pills and overly aggressively promotion that failed to disclose the possibility of blood clots, in particular. Now, though, a lawsuit charges off-label promotion for acne […]
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