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FDA Gives Advisors Surgical Mesh Reports

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FDA gives advisors surgical mesh adverse event reports to consider during a 9/8-9 meeting.

FDA Safety Alert on Merck's Saphris

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A new FDA drug safety alert warns about serious allergic reactions that have been reported with Merck's antipsychotic Saphris (ase...

FDA Accepts Avanafil NDA for Erectile Dysfunction

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FDA says it will review a Vivus avanafil NDA with a proposed indication for treating erectile dysfunction.

Dedicated Drug Development Liaison Staff Planned

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FDA releases a draft performance agreement for the PDUFA 5 reauthorization.

Advocates Push Breast Implant Ban

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Consumer advocates tell FDA advisors that the inability of breast implant manufacturers to track patients in post-approval studies...

Comments Extended on Protecting Human Research Subject Regs

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Federal Register Advanced notice of proposed rulemaking: The comment period is extended until 10/26 on how to modernize current re...

Guidance on NDA/ANDAs Format for PET Drugs

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Federal Register Notice: FDA releases a guidance on the format for NDA and ANDAs for positron emission tomography drugs.

PhRMA Defends Patent Settlements in Wake of FTC Report

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PhRMA defends industry patent settlements in the wake of an 8/31 FTC report on authorized generics.

FDA Clears Osseoflex Needle for Spine Fractures

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FDA clears an Osseon Therapeutics 510(k) for the Osseoflex SN (steerable needle) for treating spinal compression fractures.

Plea Bargain Reported Near for CDER Chemist

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Attorneys involved in the governments prosecution of a CDER chemist accused of insider trading say a plea agreement may soon be fi...