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Comments Sought on Device Premarket/Postmarket Data Collection

04/29/2015

Federal Register Notice: FDA reports on CDRH’s progress on its 2014-2015 Strategic Priority “Strike the Right Balance ...

Comments Sought on Clinical Investigator Info

04/29/2015

Federal Register Notice: FDA is seeking comments on a proposed collection of information on financial disclosure by clinical inves...

Guidance on Drugs with Estrogenic, Androgenic or Thyroid Activity

04/29/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Environmental Assessment: Questions and An...

Panel to Discuss Creutzfeldt-Jakob Disease

04/29/2015

Federal Register Notice: FDA’s Transmissible Spongiform Encephalopathies Advisory Committee will meet 6/1, from 8 a.m. to 5 ...

Notice Corrected on Pharmacoepidemiology Studies

04/29/2015

Federal Register Notice: FDA is correcting a notice entitled “Addressing Inadequate Information on Important Health Factors ...

FDA Sets Review Period for Xience Stent System

04/29/2015

Federal Register Notice: FDA has determined the regulatory review period for Abbott Cardiovascular Systems’ Xience Xpedition...

Comments Sought on Tobacco Registration/Product Listing Info

04/21/2015

Federal Register Notice: FDA is seeking public comment on the proposed extension of an existing collection of information on regis...

Guidance on Device Data from Foreign Clinical Studies

04/21/2015

Federal Register Notice: FDA is making available a draft guidance entitled Acceptance of Medical Device Clinical Data from Studies...

Public Meeting on GDUFA Reauthorization

04/21/2015

Federal Register Notice: FDA will hold a public meeting 6/15 on the Generic Drug User Fee Amendments (GDUFA) of 2012. The FD&C Act...

Workshop on Electronic Databases for Drug Safety Info

04/17/2015

Federal Register Notice: FDA and the University of Maryland Center for Excellence in Regulatory Science and Innovation will co-spo...