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Federal Register Notice: FDA is making available a draft guidance for industry entitled Recommended Warning for Over-the-Counter A...

Info on Supplement CGMPs Sent to OMB

12/02/2014

Federal Register Notice: FDA’s proposed collection of information “Current Good Manufacturing Practice in Manufacturin...

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Federal Register Notice: FDA is making available a draft guidance for industry: DSCSA Standards for the Interoperable Exchange of ...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

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...

FDA Corrects Notice on REMS

11/21/2014

Federal Register Notice: FDA is correcting a notice entitled “Report on the Standardization of Risk Evaluation and Mitigatio...

Workshop on Drug Development and Rare Subsets of Patients

11/21/2014

Federal Register Notice: FDA is announcing a public workshop 12/12 entitled “Developing and Using Precision Therapies in the...