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Change Ethical Issues for Kids Products: AdvaMed

[ Price : $8.95]

AdvaMed asks FDA to consider adding more information to a draft guidance on ethical considerations for clinical investigations of ...

2 Comments on Computer Software Assurance Guidance

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Two stakeholders comment on an FDA draft guidance on computer software assurance.

Adcetris OKd for Pediatric High-risk Hodgkin Lymphoma

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FDA approves Seagens Adcetris (brentuximab vedotin) for treating pediatric patients with previously untreated high risk classical ...

FDA Refuses to File NurOwn BLA

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FDA refuses to file a BrainStorm Cell Therapeutics BLA for its NurOwn to treat ALS.

Strengthen AI Product Approval: Researchers

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Yale University researchers say FDA should strengthen its regulatory approach to artificial intelligence products used in breast c...

Draft Guide on ANDA Sameness Evaluations

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Federal Register notice: FDA makes available a draft guidance entitled Sameness Evaluations in an ANDA Active Ingredients.

Panel Backs AstraZeneca Asthma Product in Adults

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FDAs Pulmonary-Allergy Drugs Advisory Committee votes 16 to 1 to support approval of an AstraZeneca NDA for PT027 (albuterol/budes...

ZoomRx Keys to Better Oncology Promo Messaging

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ZoomRx suggests three ways to create effective oncology promotional messages directed to healthcare providers.

18 Observations on Lupin FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Lupin manufacturing facility in Pune, Maharashtra, India.

ImprimisRx NJ FDA-483 Has 9 Observations

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FDA releases the form FDA-483 issued following an inspection at Ledgewood, NJ-based Imprimis Rx NJ.