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FDA Approves Amphastar Generic Lovenox

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After years of contention, FDA approves Amphastars ANDA for a generic form of Lovenox.

FDA Clears Toshiba Imaging Interface

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FDA clears Toshibas M-Power magnetic resonance imaging customizable user interface.

FDA Holding Clinical Investigator Training Course

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FDA releases the draft agenda for an 11/7-9 clinical investigator training course.

Risk Communication Panel to Meet

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Federal Register Notice: FDAs Risk Communication Advisory Committee will meet 11/17-18 to discuss communicating quantitative risk ...

Comments Sought on Exculpatory Language Change

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FDA and HHS ask for comment on a draft guidance changing acceptable exculpatory language in informed consent documents.

VentriPoint Imaging Application Due by Years End

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VentriPoint says it will use data from a current clinical trial in an application to FDA by the end of this year for its VMS 3D im...

FDA Tentatively Approves Matrix PEPFAR Drugs

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FDA tentatively approves Matrix Laboratories HIV/AIDS drug cocktail for use outside the U.S. in the PEPFAR program.

FDA Changes Coming Under PIC/S Inspectorate Role

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FDA Office of Regulatory Affairs strategic initiatives executive director Brenda Holman updates a regulatory conference on agency ...

CDER Pilot Program Speeds Up Drug Recall Postings

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CDER begins a new pilot program where it now posts drug recall information in its weekly Enforcement Report before the recall has ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Biolab Company, Chronicity, Covenant HealthCare, Eagle Diagnostics, Sam-Go Produ...