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FDA Clears AdvaDx mecA XpressFISH Assay

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FDA clears an AdvanDx 510(k) for its new mecA XpressFISH assay for detecting methicillin-resistant and methicillin-susceptible Sta...

High-powered Lawyers Fighting LDT Proposal

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The American Clinical Laboratory Association says former solicitor general Paul Clements and Harvard law professor Lawrence Tribe ...

FDA Revises Guidance on 505(q) Citizen Petitions

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FDA posts a revised guidance on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q)of the Federal Food, D...

OIG Lists FDA Drug Safety Tasks

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The HHS Inspector General says there a number of tasks FDA needs to do to continue to ensure the safety of drugs and medical devic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Eastern Pharmacy, Dr. Benedict Schue-Schie Liao, MKL Diagnostics, Wells Pharmacy...

FDA Approves Safety Labeling Changes for 37 Drugs

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FDA approves safety labeling changes for 37 drugs including a Boxed Warning about suicidality for Lillys Cymbalta.

Agency Pushes Back ANDA Labeling Final Rule

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FDA delays finalizing a proposed rule that would require generic drug makers to use the same process as brand drug manufacturers t...

Comments Sought on ANDA Priority Reviews for First Generics

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FDA opens a public docket requesting comments on proposed criteria for first generic ANDA submissions in order for the agency to s...

FDA Clears Aurora Spines Spinal Implant

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FDA clears an Aurora Spine Corp. 510(k) for its Zip 51, an interspinous fixation implant for spinal fusion procedures.

FDA, CDC Award Contract for Vaccine Adverse Event System

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FDA and the Centers for Disease Control and Prevention award SRA International an $18 million contract to support the Vaccine Adve...