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Review Period Set for Xeljanz

06/12/2015

Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Xeljanz (tofacitinib citrate) is 3,947...

FDA Sends Info on Device Recall Authority to OMB

06/12/2015

Federal Register Notice: FDA’s proposed collection of information, “Medical Device Recall Authority — 21 CFR 810...

FDA Sends Info on Device Reclassification Petitions to OMB

06/12/2015

Federal Register Notice: FDA submits a proposed collection of information entitled “Reclassification Petitions for Medical D...

Guidance on Cell-Based Products for Animal Use

06/12/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Cell-Based Products for Animal Use. The document...

OMB Approves Info on Risk/Benefit Perception Scale

06/09/2015

Federal Register Notice: FDA’s collection of information entitled “Risk and Benefit Perception Scale Development,&rdqu...

OMB OKs Info on Tobacco Prevention

06/09/2015

Federal Register Notice: FDA’s collection of information entitled “Evaluation of the Food and Drug Administration&rsqu...

OMB OKs Info on Single-Use Devices

06/09/2015

Federal Register Notice: FDA’s collection of information entitled “Prominent and Conspicuous Mark of Manufacturers on ...

OMB OKs Info on DTC Ads

06/03/2015

Federal Register Notice: FDA’s collection of information entitled, “Disclosure Regarding Additional Risks in Direct-to...

OMB OKs Info on Orphan Products Development

06/03/2015

Federal Register Notice: FDA’s collection of information entitled, “Guidance for Industry, Researchers, Patient Groups...

Info on Biosimilars User Fee Sent to OMB

06/03/2015

Federal Register Notice: FDA’ s proposed collection of information, “Biosimilars User Fee Cover Sheet; Form FDA 3792,&...