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Info on Patents Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on patent submission and listing requirements to the Off...

Multiple Violations Found at Y.S. Health

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FDAs Chicago District Office warns Y.S. Health about violations of dietary supplement CGMP regulations as well as distributing una...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Brower Enterprises, Gum Runners, and Y.S. Health.

PhRMA Suggests REMS Standardization Changes

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PhRMA suggests ways FDA can improve its efforts to standardize REMS.

Petition Wants Additional Cefdinir RLD

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Hyman, Phelps & McNamara asks FDA to designate one of four ANDA-approved companies making cefdinir for oral suspension as a second...

Hamburgs Big Field Shakeup Will be a Feeding Frenzy

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John Scharmann sees commissioner Hamburgs Program Alignment Group field shakeup as an organizational feeding frenzy and identifies...

CDER Advertising Staff Focusing on Guidance Development

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CDERs Office of Prescription Drug Promotion says guidance development is one of its top priorities this year.

Bayer Animal Health Challenges Norbrook on its Euroflox

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Bayer Animal Health tells FDA that Norbrook Laboratories is unable to provide a factual finding that users of its Euroflox would f...

FDA Denies Treanda Petition

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FDA denies a Center for Medicine in the Public Interest petition seeking requirements to be placed on applicants for a sNDA for a ...

CDC Backs FDA Efforts on Antibiotics

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The Centers for Disease Control says it backs FDAs strategy for minimizing inappropriate use of antibiotics in humans and animals....