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Info on User Fee Cover Sheet Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on the user fee cover sheet to the Office of Management ...

Comments Sought on Influenza A Reagent Guidance

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Federal Register Notice: FDA seeks comments on a guidance on reagents for detecting influenza A viruses.

Guidance on Drugs for E-coli in Cattle

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Federal Register Notice: FDA releases a guidance: Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic...

CDRHs Top 10 Regulatory Science Priorities

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A new CDRH regulatory science outline the top 10 priorities for 2016, including leveraging big data and evidence from clinical exp...

Avedro Resubmits NDA for Keratoconus/Corneal Ectasia

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Avedro resubmits an NDA for riboflavin ophthalmic solution/KXL System for corneal cross-linking.

Hillary Clinton Asks FDA for Help With Drug Pricing Issue

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Democratic presidential candidate Hillary Clinton makes the escalating cost of certain drugs a campaign issue, as well as the need...

FDA Grants Pfizer Breakthrough Status for Leukemia Therapy

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FDA grants Pfizer a breakthrough therapy designation for its investigational antibody-drug conjugate inotuzumab ozogamicin for tre...

FDA Wants More Data on Shire Eye Drug

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FDA issues Shire plc a complete response letter requesting an additional clinical study for its NDA for lifitegrast, indicated for...

FDA Accepts NDA for Tarsa Osteoporosis Drug

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FDA accepts for review a Tarsa Therapeutics NDA for Tbria (calcitonin-salmon [rDNA origin] delayed release tablets), indicated for...

Obesity Groups Seek FDA Approval for Dietary Supplements

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Four obesity research, treatment and prevention groups call on Congress to reform the 1994 Dietary Supplement Health and Education...