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Info Collection Revision on CLIA Waivers

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Federal Register notice: FDA seeks comments on an information collection revision entitled Administrative Procedures for Clinical ...

Advisors to Consider Acadias Nuplazid for Alzheimers Psychosis

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FDA says its Psychopharmacologic Drugs Advisory Committee will consider whether data from Acadia Pharmaceutical trials support an ...

Alston & Bird Attorneys Review PDUFA 7 Provisions

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Four Alston & Bird attorneys describe some of the major items in the PDUFA 7 reauthorization legislation that has bipartisan suppo...

Pfizer Stops Enrolling Standard Risk Patients in Paxlovid Trial

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Pfizer says it will stop enrolling standard risk patients in the EPIC-SR trial of its anti-Covid therapy Paxlovid and submit data ...

Senate HELP Committee Passes FDA User Fee Bill

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The Senate Health, Education, Labor and Pensions Committee passes the FDA Safety and Landmark Advancements (FDASLA) Act, which rea...

Draft Guide on Quality Risk Management

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Federal Register notice: FDA makes available a draft guidance for industry entitled Q9(R1) Quality Risk Management (QRM).

CDERs Cavazzoni Spearheading Rare Disease Program

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CDER director Patrizia Cavazzoni tells FDLI she is personally spearheading the Centers new rare disease efforts to speed and incre...

Regenerative Medicine Consensus Standard Guidance

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FDA publishes a draft guidance on the voluntary consensus standards recognition program for regenerative medicine therapies.

Panel Backs Pfizer, Moderna Covid Vaccines in Young Kids

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FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes to recommend the agency expand the Covid-19 eme...

Quantitative Imaging Assessment in Premarket Submissions

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FDA publishes a guidance with recommendations for manufacturers on information to go in premarket submissions for radiological dev...