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Comments Sought on FDA Drug Communications

04/07/2014

Federal Register Notice: FDA is seeking public comment on a proposed collection of information on a generic clearance to collect i...

Comments Sought on Biologic AERS, General Records

04/07/2014

Federal Register Notice: FDA is seeking comment on a proposed collection of information related to FDA’s Adverse Experience ...

FDA Corrects Huvepharma NADA Withdrawal

04/07/2014

Federal Register Notice: FDA published a document in 2/27 Federal Register on the voluntary withdrawal of approval of NADAs. The d...

Guidance on Advisory Panelists’ Financial Information

03/31/2014

Federal Register Notice: FDA is making available a guidance entitled Guidance for the Public, Food and Drug Administration Advisor...

Workshop Planned on FDA and Global Product Safety

03/31/2014

Panel to Discuss Pediatric Safety Reviews

03/31/2014

Review Period Set for Prevnar

03/31/2014

Review Period Set for Nulojix

03/31/2014

Federal Register Notice: FDA has determined the regulatory review period for Nulojix is 4,479 days for extending a patent which cl...

FDA Corrects Withdrawn NADA

03/31/2014

Federal Register Final rule: FDA is correcting a document amending the animal drug regulations to reflect the withdrawal of approv...

Comments Sought on OTC Drug Classification Criteria

03/24/2014