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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...

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...

Comments Sought on Rx Drug Administrative Procedures

11/14/2014

Federal Register Notice: FDA is seeking comments on the information collection in the regulations in the Prescription Drug Marketi...

Comments Sought on New Dietary Ingredient Safety Procedures

11/14/2014

Federal Register Notice: FDA is seeking public comment on the procedure by which a manufacturer or distributor of a new dietary in...