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FDA takes action against 14 companies for selling illegal cancer treatments
worldpharmanews
April 26, 2017
The U.S. Food and Drug Administration today posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.
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Zydus Cadila gets US FDA nod for anti-hypertensive tabs
financialexpress
April 26, 2017
The drug will be produced at the group’s formulations manufacturing facility in Ahmedabad
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Quality by Design -- Experimental strategies for implementing Quality by Design
Ronald D. Snee, PhD
April 25, 2017
Much has been learned about the use of Quality by Design (QbD) since it was proposed by the FDA and ICH (2005) some five years ago. While the benefits of the approach are generally acknowledged, its implementation has been slower than expected.
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FDA Restricts use of Prescription Codeine Pain, Cough Medicines, Tramadol Pain Medicines in Children
americanpharmaceuticalreview
April 24, 2017
The Food and Drug Administration (FDA) is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain.
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Sun Pharma receives 11 observations from US FDA for Dadra plant
financialexpress
April 24, 2017
The news has caused Sun Pharma’s stock to fall as much as three per cent
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FDA restricts administration of strong pain killers to children
pharmafile
April 24, 2017
The FDA has announced that it will require medication including codeine and tramadol, two high-strength...
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FDA rejects Vernalis’ cough cold treatment
pharmatimes
April 24, 2017
The US Food and Drug Administration has rejected Vernalis’ cough cold treatment CCP-07, which is being developed by US partner Tris Pharma.
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FDA Approves Renflexis
drugs.com
April 24, 2017
FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
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Aurobindo Pharma gets six observations from US FDA for Hyderabad unit
financialexpress
April 21, 2017
US FDA had conducted an inspection at the company’s Unit III, a formulations manufacturing facility at Bachupally, Hyderabad
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FDA approves Genentech’s Lucentis for diabetic retinopathy
cphi-online
April 21, 2017
First and only medicine FDA-approved to treat all forms of diabetic retinopathy.