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Guide on Device Human Factors Submission Info

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Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Subm...

Proposal to Exempt Dietary Supplements in Some Drug Studies

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Federal Register proposed rule: FDA proposes to amend its regulations on INDs to exempt certain clinical investigations of lawfull...

Proposal to Replace IND Annual Reporting Requirement

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Federal Register proposed rule: FDA proposes to replace its current annual reporting requirement for INDs with a new requirement: ...

Remel Recalls Thermo Scientific Sensititre Plates

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Remel recalls Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for...

Janssen Files BLA for Myeloma Therapy

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Janssen Pharmaceutical files a BLA for talquetamab for treating patients with relapsed or refractory multiple myeloma.

2 Roche Alzheimers Tests Cleared by FDA

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FDA grants Roche 510(k) clearance for its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Phospho-Tau (181P) CSF (pTau181...

Input Sought on Advanced Manufacturing Paper

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FDA seeks feedback on a discussion paper entitled Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.

35 No-Longer-Marketed NDAs Withdrawn

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Federal Register notice: FDA withdraws approval of 35 NDAs at the request of their sponsors.

ICH Continuous Manufacturing Guide Adopted

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FDA adopts an international guidance entitled Continuous Manufacturing of Drug Substances and Drug Products Q13.

Guide on Transfusion-Transmitted Malaria

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Federal Register notice: FDA makes available a final guidance entitled Recommendations to Reduce the Risk of Transfusion-Transmitt...