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Guidance on Tracing Rx Drugs

12/02/2014

Federal Register Notice: FDA is making available a draft guidance for industry: DSCSA Standards for the Interoperable Exchange of ...

Guidance on Infusion Pumps

12/02/2014

Federal Register Notice: FDA is making available final guidance entitled, Infusion Pumps Total Product Life Cycle; Guidance for In...

Guidance on SUPAC Manufacturing Equipment

12/02/2014

Federal Register Notice: FDA is making available a guidance: SUPAC: Manufacturing Equipment Addendum. It replaces the draft guidan...

Guidance on Product Labeling on the Absence of Latex

12/02/2014

Federal Register Notice: FDA is making available a guidance entitled Recommendations for Labeling Medical Products to Inform Users...

Docket Opened on E-Cigarettes

12/02/2014

Federal Register Notice: FDA’s Center for Tobacco Products is establishing a public docket in conjunction with the first pub...

Tobacco Collection of Info Sent to OMB

12/02/2014

Federal Register Notice: FDA’s proposed collection of information “Generic Clearance for the Collection of Quantitativ...

Guidance on OTC Acetaminophen Drugs and Skin Reactions

12/02/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Recommended Warning for Over-the-Counter A...

Comments Sought on Animal Food/Feed Prohibited Substances

11/21/2014

Federal Register Notice: FDA is seeking public comments on the recordkeeping requirements for substances prohibited for use in ani...

Panel to Discuss Astellas NDAs for Aspergillosis/Mucormycosis

11/21/2014

Federal Register Notice: FDA’s Anti-Infective Drugs Advisory Committee will meet 1/22/15, from 8 a.m. to 5 p.m. at the FDA W...

Guidance on Changes to Blood Product Application

11/21/2014

Federal Register Notice: FDA is making available a guidance document: Changes to an Approved Application: Biological Products: Hum...