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Searching Content indexed under Food and Drugs Law by M. David Weingarten ordered by Published Date Descending.
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Podcast: Navigating Orange Book Listings
The Drug Price Competition and Patent Term Restoration Act of 1984–also known as the Hatch-Waxman Act–amended patent law ...
United States
6 Nov 2018
2
FDA Draft Guidance On Indications And Usage Labeling
On July 6, 2018, the U.S. Food and Drug Administration (FDA) issued draft guidance to assist applicants in writing the Indications and Usage section of labeling for human prescription drug
United States
20 Aug 2018
3
Requirements, Benefits, And Possible Consequences Of Listing Patents In FDA's Orange Book
NDAs must be accompanied by certain patent information, which the FDA then lists in its Approved Drug Products with Therapeutic Equivalence Evaluations publication.
United States
20 Jul 2018
4
FDA Final Guidance On: Bioanalytical Method Validation
On May 21, 2018, FDA issued final guidance on Bioanalytical Method Validation. The guidance incorporates public comments to the revised draft published in 2013 ...
United States
30 May 2018
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