Tag:
FDA guidance
Latest Headlines
Latest Headlines
FDA unveils guidance on how PMAs, de novo submissions are reviewed
Unpredictable is one term devicemakers have used to describe the premarket approval and de novo submission process with the FDA. But now, a ray of hope for some clarity.
How much cheaper will biosimilars be?
By Peyton Howell The pharma industry has begun a new chapter of the biosimilars story. We now have much-anticipated guidance from the FDA on what the approval pathway will look like, what evidence...
FDA sees advances in manufacturing as key to biosimilar abbreviated path
It looks as if the advanced state of pharmaceutical manufacturing in the U.S. will pave the abbreviated pathway to the making of biosimilars. The FDA last week issued its highly anticipated draft...
FDA asks heparin makers to test APIs for contaminants, including BSE
Citing patient deaths from contaminated heparin from China, the FDA has released recommendations that manufacturers test crude heparin to make sure the ingredient comes only from pig intestines. The...
Seeking middle ground for the FDA
Thinking out loud here. There has to be some message about pharma industry regulation when the first update to a core guidance document appears 24 years after the original. That's the case with the
Statistics star in validation guidance update
In new guidance, Process Validation: General Principles and Practices, the FDA updates the venerable Guideline on General Principles of Process Validation published in 1987. The regulator says the
FDA reveals plans for upcoming guidance
In releasing details of its plans for upcoming guidance document topics, the FDA reveals to industry what's on its mind. Consider this list in any upcoming ops planning. Topics are organized by FDA
Safety advocates say FDA guidance not enough
The FDA guidance to sniff for the contaminant TBA has been proven effective by Pfizer [ see related story ]. But some have begun to question the effectiveness of FDA guidance on the whole. The food
FDA reminds, guides on fighting musty odor
Give wooden pallets the sniff test and get certification from suppliers that no halogenated phenolic preservatives have been used in the lumber. That's guidance from the FDA, which also reminds
FDA proposes QbD methods for skin patches
In recently issued draft guidance, the FDA advocates Quality by Design principles in the manufacture and development of skin-patch drugs. The document covers transdermal and transmucosal drug
