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Guidance on Drug Development for COPD

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Federal Register Notice: FDA releases a draft guidance on developing drugs for chronic obstructive pulmonary disease.

Comments Sought on Device Fellowship Program

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Federal Register Notice: FDA seeks comments on an application for participating in the Medical Device Fellowship Program.

Info on Orphan Products Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the joint FDA/EMEA application form on orphan product...

Panel to Discuss Permanent Sterilization Method

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Federal Register Notice: FDAs Obstetric and Gynecology Devices Panel will meet 12/13-14 to discuss a Cytyc Surgical Products PMA f...

FDA Clears Baxters Needleless IV Connector

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FDA clears a Baxter Healthcare 510(k) for the V-Link Luer-activated device, a needleless IV connector containing an antimicrobial ...

Trial Protocol Cleared on Abuse-Deterrent Oxycodone

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FDA and Elite Pharmaceuticals agree on the design of a Phase 3 trial involving ELI-216, the companys abuse deterrent oxycodone pro...

FDA Clears Laser for Pain Relief

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FDA clears a Multi Radiance Medical 510(k) for the TerraQuant therapeutic laser device intended to relieve chronic and acute pain.

Erythropoiesis Drugs Labeling Revised

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FDA releases new boxed warnings and other safety-related labeling changes for Amgens Epogen, Procrit, and Aranesp.

Public Meeting Slated on Epinephrine MDIs

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Federal Register Proposed rule: FDA plans a public meeting 12/5 and is extending the comment period on removing the essential-use ...

Blood Regulations Updated

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Federal Register Proposed rule: FDA proposes to update the blood and blood regulations to add donor requirements consistent with c...