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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.
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.
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
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...
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.
FDA Approves Renflexis drugs.com
April 24, 2017
FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
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
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.
FDA grants Breakthrough Therapy designation to Novartis CTL019 for DLBCL pharmaceutical-technology
April 20, 2017
Novartis’ investigational chimeric antigen receptor T-cell (CAR-T) therapy, CTL019, has received Breakthrough Therapy ...
Rigel Pharmaceuticals submits NDA to FDA for Fostamatinib to treat chronic ITP pharmaceutical-technology
April 20, 2017
Rigel Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for...

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