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Guidance on Human Factor Studies for Combo Products

02/03/2016

Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Human Factors Studies and Re...

Comments Sought on Combo Product Assignment Procedure

01/28/2016

Federal Register Notice: FDA seeks public comments on the procedure by which an applicant may obtain an assignment or designation ...

Draft Guidance on Lamotrigine BE Recommendations

01/28/2016

Federal Register Notice: FDA is making available a revised draft guidance for industry on lamotrigine extended-release tablets ent...

FDA Releases Product-Specific BE Guidance

01/28/2016

Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...

FDA, Xavier University Plan Device Conference

01/28/2016

Federal Register Notice: FDA’s Cincinnati District and Xavier University will co-sponsor a public conference 5/4-6 entitled ...

FDA Renews Pharm. Science Advisory Committee Charter

01/22/2016

Federal Register Notice: FDA is renewing the Pharmaceutical Science and Clinical Pharmacology Advisory Committee (formerly known a...

Guidance on Postmarket Device Cybersecurity

01/22/2016

Federal Register Notice: FDA is making available a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devic...

FDA Corrects Notice on Arthritis Advisory Cmte. Meeting

01/22/2016

Federal Register Notice: FDA is correcting a 1/19 Federal Register notice announcing the Arthritis Advisory Committee meeting set ...

Cranial Electrotherapy Devices into Class 2

01/22/2016

Federal Register Proposed order: FDA proposes an administrative order to reclassify the cranial electrotherapy stimulator (CES) de...

Panel to Hear Research Program Updates

01/21/2016

Federal Register Notice: FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet 2/16 from 1 p.m. to 5 p.m. a...