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FDA Denies Kuvan Bioequivalence Petition

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FDA denies a petition to permit a drug company to submit an ANDA demonstrating bioequivalence to BioMarins Kuvan sold in Israel ra...

Mallinckrodt Asks Court to Nix FDA Action on Generic Concerta

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Mallinckrodt asks a Maryland federal court to stop FDA from reclassifying its generic form of Concerta from AB to BX.

Gilead Buys Priority Review Voucher for $125 Million

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Knight Therapeutics sells to Gilead Sciences for $125 million its Neglected Tropical Disease Priority Review Voucher that was gran...

FDA Grants Merrimack Pharma Fast Track Status for MM-398

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FDA grants Merrimack Pharmaceuticals a fast track designation for MM-398 (nanoliposomal irinotecan injection) for treating patient...

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...

QS Violations Found at MKL Diagnostics

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FDA warns Swedens MKL Diagnostics about Quality System violations in its production of diagnostic tests.

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...