10.20.2020

GDUFA Paid Facilities List

This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:
10.20.2020

Generic Drug Facilities, Sites and Organization Lists

Generic Drug Facilities, Sites and Organization Lists
10.20.2020

Biden looks to Germany for answers on how to tackle high U.S. drug prices: analyst

Biden looks to Germany for answers on how to tackle high U.S. drug prices: analyst esagonowsky Tue, 10/20/2020 - 09:33
10.20.2020

Medoz Pharmacy of Polk Inc - 610467 - 09/25/2020

Compounding Pharmacy/Adulterated Drug Products
10.20.2020

RLC Labs Inc. - 607596 - 10/09/2020

CGMP/Finished Pharmaceuticals/Adulterated
10.20.2020

Before Brands Inc - 607630 - 10/09/2020

New Drug/Misbranded
10.20.2020

Bristol Myers, Exelixis get in FDA fast lane for Opdivo-Cabometyx combo in kidney cancer

Bristol Myers, Exelixis get in FDA fast lane for Opdivo-Cabometyx combo in kidney cancer aliu Tue, 10/20/2020 - 09:05
10.20.2020

Newly Added Guidance Documents

Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
10.20.2020

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry

Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
10.20.2020

Roche drops $500M into new global operations hub, with 500 jobs to follow

Roche drops $500M into new global operations hub, with 500 jobs to follow kblankenship Tue, 10/20/2020 - 08:52