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Federal Register Notice: FDA is making available a draft guidance for industry entitled Distributor Labeling for New Animal Drugs....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Federal Register Notice: FDA is making available a draft guidance for industry entitled Nonproprietary Naming of Biological Produc...

FDA Proposes 6 Biological Product Names

08/28/2015

Federal Register Proposed rule: FDA is proposing a regulation to designate official names and proper names for certain biological ...

Guidance on No-Tobacco-Sale Order

08/28/2015

Federal Register Notice: FDA is making available a guidance for tobacco retailers entitled Determination of the Period Covered by ...

Comments Extended on Quality Metrics Guidance/Meeting

08/26/2015

Federal Register Notice: FDA is extending the comment period until 11/27 for a 7/28 and 8/7 Federal Register notice of a draft gui...

FDA Submits Device Reporting Info to OMB

08/26/2015

Federal Register Notice: FDA’s proposed collection of information “Medical Device Reporting: Manufacturer, Importer, U...