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FDA Sets Fees for Tropical Disease Priority Review

09/14/2015

Federal Register Notice: FDA is announcing the fee rates for using a tropical disease priority review voucher for fiscal year 2016...

FDA Issues EUA for Ebola Diagnostic

09/14/2015

Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detection of the Ebol...

Guidance on Provisional Tobacco Product Enforcement

09/14/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Enforcement Policy for Certain (Provisional) Tob...

Panel to Discuss Organon NDA

09/14/2015

Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet 11/6, from 8 a.m. to 5 p....

Public Meeting on Drug Interactions with Hormonal Contraceptives

09/11/2015

Federal Register Notice: FDA will hold a public meeting 11/9 entitled “Drug Interactions with Hormonal Contraceptives(HCs): ...

OMB OKs Info on Investigational Animal Drugs

09/10/2015

Federal Register Notice: FDA’s collection of information entitled, “New Animal Drugs for Investigational Use,” h...

Guidance on Distributor Labeling for Animal Drugs

09/10/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Distributor Labeling for New Animal Drugs....

Workshop Slated on Osteoporosis Drug Development

09/10/2015

Federal Register Notice: CDER’s Division of Bone, Reproductive, and Urologic Products will hold a public workshop 11/4 entit...

ICH Guidance on Elemental Impurities for Drugs

09/10/2015

Federal Register Notice: FDA is making available a guidance entitled Q3D Elemental Impurities, prepared under the auspices of the ...

Guidance on Naming Biological Products

08/28/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonproprietary Naming of Biological Produc...