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Lilly Withdraws Cymbalta sNDA for Pain

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Eli Lilly withdraws a supplemental NDA for Cymbalta (duloxetine HCl) seeking a new indication for managing chronic pain.

FDA OKs Elanco Animal NADA for Turkey Feed

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Federal Register Final rule: FDA approves an Elanco Animal Health NADA for use of ractopamine hydrochloride to make medicated feed...

Time Changed on Pediatric Ethics Subcommittee Meeting

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Federal Register Notice: FDA changes the time for public oral presentations in its Pediatric Ethics Subcommittee meeting scheduled...

FDA Revokes Cephalosporin Prohibition

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Federal Register Final rule: FDA revokes its order prohibiting extralabel use of cephalosporin antimicrobial drugs in food-produci...

Guidance on Substances Prohibited in Animal Feed

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FDA releases a draft guidance for renderers on substances prohibited from use in animal food or feed in order to prevent the sprea...

Info on Med Guide Requirements Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on prescription drug product labeling and medication guide...

Comments Sought on TV Drug Ad Toll-Free Numbers

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Federal Register Notice: FDA seeks comments on a study examining consumer comprehension of a toll-free number included in DTC pres...

Workshop on Sex Differences in Cardio Device Trials

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Federal Register Notice: FDA and AdvaMed co-sponsor a public workshop 12/9 on sex differences in cardiovascular device trials.

FTC Proposes Endorsement Guide Changes

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The Federal Trade Commission will take public comment on proposed changes to its guides for advertising that uses endorsements and...

FDA Delays Approval of J&J Antibiotic

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An FDA complete response letter rejects J&Js NDA for ceftobiprole until additional audit work of clinical investigator sites is pr...