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FDA Making Less Use of Advisory Committees: Analysis

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Eye on FDA notes a reduction in the number of drug-related advisory committee meetings this year and whether this can be seen as l...

Low Number of Drug Recalls in Third Quarter: Stericycle

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The Stericycle Expert Solutions third quarter recall index shows a lower number of prescription drug recalls and a very high numbe...

Braeburn Says Brixadi Can Be Marketed 12/1/20

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Braeburn says its Brixadi treatment for opioid use disorder is available to be marketed 12/1/20 after FDA revoked the orphan drug ...

Export Certificate Review Process Guidance

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FDA issues a guidance explaining the process to seek review of a Certificate to Foreign Government denial.

Supreme Court to Consider Disgorgement Legality

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Ropes & Gray says the Supreme Court will consider whether the SEC has the legal authority to seek disgorgement as an enforcement t...

GSK Seeking Nucala Approval in Hypereosinophilic Syndrome

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GlaxoSmithKline says it will seek approval for Nucala (mepolizumab) for treating patients living with Hypereosinophilic Syndrome b...

Workshop on Clinical Outcome Assessments

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Federal Register notice: FDA announces a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for reg...

FDA Starts TMD/TMJ Web Pages

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FDA launches temporomandibular disorders Web pages.

Info Collection on Combo Product Jurisdiction

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Federal Register notice: FDA sends to OMB an information collection extension for Product Jurisdiction: Assignment of Agency Compo...

CGMP Deviations Found in Mylan Unit 8

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FDA warns Mylan about significant deviations from CGMP requirements for active pharmaceutical ingredients at its Unit 8 in India.