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3 Observations on Reliance Life Sciences FDA-483

[ Price : $8.95]

FDA releases the Form FDA-483 issued following an inspection at Indias Reliance Life Sciences drug manufacturing facility in Navi ...

PDUFA VIII Commitment Letter Outlines Changes to Drug Review, Manufacturing Oversight

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FDA releases the proposed recommendations for the eighth reauthorization of the Prescription Drug User Fee Act, outlining changes ...

Guidance on Risk-Based Approach to Drug Packaging Systems

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FDA issues a draft guidance proposing a risk-based framework for evaluating the container-closure systems used to package human dr...

Experts Warn of Edema Risk With Vykat XR as FDA Evaluates Risk

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Foundation for Prader-Willi Research warns that real-world reports of edema and other serious heart and respiratory problems among...

FDA Expedited IND to Lean on Rolling Submissions/Reviews

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FDA officials detailing the agencys new expedited IND pilot program say a central feature will be a rolling pre-IND submission pro...

Lilly Files Six Lawsuits Over Illegal Retatrutide Sales

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Eli Lilly files six new lawsuits against U.S. entities it alleges are selling illegal, unapproved retatrutide products.

Ban Infants Tylenol: Childrens Health Defense

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Childrens Health Defense petitions FDA to ban Infants Tylenol and place Boxed Warnings on labeling for some other Tylenol products...

Use More Advisory Committee Temporary Voting Members: Column

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A Center for Medicine in the Public Interest opinion column calls on FDA to more aggressively recruit and use advisory committee t...

FDA Obstacles Lead to Overseas Trials: Survey

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A survey of 37 biotech executives shows FDA obstacles are sending more first-in-human trials overseas.

Theresa Mullin Retires as CDER Associate Director

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CDER associate Center director for strategic initiatives Theresa Mullin retires after 28 years at the agency.